End effector coupling arrangements for a surgical cutting and stapling instrument

ABSTRACT

In various embodiments, a surgical stapling instrument can include a handle, a shaft extending from the handle, wherein the shaft defines an axis, and a disposable loading unit which is assembled to the shaft in a direction which is transverse to the shaft axis. Such a connection between the disposable loading unit and the shaft can prevent, or at least inhibit, the disposable loading unit from being unintentionally displaced proximally and/or distally relative to the shaft of the surgical instrument. The surgical stapling instrument and/or disposable loading unit can further include a threaded collar and/or detent assembly configured to hold the disposable loading unit in place. In various embodiments, a disposable loading unit can include a lockout feature which can prevent, or at least inhibit, an expended disposable loading unit from being reassembled to the elongated body of the surgical instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation application claiming priorityunder 35 U.S.C. § 120 from U.S. patent application Ser. No. 14/528,626,entitled END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTTING ANDSTAPLING INSTRUMENT, filed Oct. 30, 2014, now U.S. Patent ApplicationPublication No. 2015/0060521, which is a continuation applicationclaiming priority under 35 U.S.C. § 120 from U.S. patent applicationSer. No. 13/027,641, entitled END EFFECTOR COUPLING ARRANGEMENTS FOR ASURGICAL CUTTING AND STAPLING INSTRUMENT, filed Feb. 15, 2011, whichissued on Nov. 4, 2014 as U.S. Pat. No. 8,875,972, which is acontinuation application claiming priority under U.S.C. § 120 from U.S.patent application Ser. No. 12/031,817, entitled END EFFECTOR COUPLINGARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT, filed Feb.15, 2008, now U.S. Patent Application Publication No. 2009/0206131, theentire disclosures of which are hereby incorporated by reference herein.

BACKGROUND

1. Technical Field

This application relates to a surgical stapling apparatus and, invarious embodiments, to an articulating mechanism for use with anendoscopic surgical stapling apparatus for sequentially applying aplurality of surgical fasteners to body tissue and optionally incisingfastened tissue.

2. Background of Related Art

Surgical devices wherein tissue is first grasped or clamped betweenopposing jaw structures and then joined by surgical fasteners are wellknown in the art. In some instruments, a knife is provided to cut thetissue which has been joined by the fasteners. The fasteners aretypically in the form of surgical staples but two part polymericfasteners can also be utilized.

Instruments for this purpose can include two elongated members which arerespectively used to capture or clamp tissue. Typically, one of themembers carries a staple cartridge which houses a plurality of staplesarranged in at least two lateral rows while the other member has ananvil that defines a surface for forming the staple legs as the staplesare driven from the staple cartridge. Generally, the stapling operationis effected by cam bars that travel longitudinally through the staplecartridge, with the cam bars acting upon staple pushers to sequentiallyeject the staples from the staple cartridge. A knife can travel betweenthe staple rows to longitudinally cut and/or open the stapled tissuebetween the rows of staples. Such instruments are disclosed, forexample, in U.S. Pat. No. 3,079,606 and U.S. Pat. No. 3,490,675, theentire disclosures of which are hereby incorporated by reference herein.

A later stapler disclosed in U.S. Pat. No. 3,499,591, the entiredisclosure of which is hereby incorporated by reference herein, appliesa double row of staples on each side of the incision. This isaccomplished by providing a disposable loading unit in which a cammember moves through an elongate guide path between two sets ofstaggered staple carrying grooves. Staple drive members are locatedwithin the grooves and are positioned in such a manner so as to becontacted by the longitudinally moving cam member to effect ejection ofthe staples from the staple cartridge of the disposable loading unit.Other examples of such staplers are disclosed in U.S. Pat. Nos.4,429,695 and 5,065,929, the entire disclosures of which are herebyincorporated by reference herein.

Each of the instruments described above were designed for use inconventional surgical procedures wherein surgeons have direct manualaccess to the operative site. However, in endoscopic or laparoscopicprocedures, surgery is performed through a small incision or through anarrow cannula inserted through small entrance wounds in the skin. Inorder to address the specific needs of endoscopic and/or laparoscopicsurgical procedures, endoscopic surgical stapling devices have beendeveloped and are disclosed in, for example, U.S. Pat. Nos. 5,040,715;5,307,976; 5,312,023; 5,318,221; 5,326,013; and 5,332,142, the entiredisclosures of which are hereby incorporated by reference herein.

Many current laparoscopic linear stapling devices are configured tooperate with disposable loading units and staple cartridges of only onesize. For example, individual linear staplers are presently availablefor applying parallel rows of staples measuring 30 mm, 45 mm and 60 mmin length, for example. Thus, during a normal operation, a surgeon maybe required to utilize several different stapling instruments to performa single laparoscopic surgical procedure. Such practices increase thetime, complexity and overall costs associated with laparoscopic surgicalprocedures. In addition, costs are greater in designing andmanufacturing multiple stapler sizes, as opposed to creating a single,multipurpose stapler.

It would be extremely beneficial to provide a surgical device for useduring laparoscopic and/or endoscopic surgical procedures that can beemployed with several different sized disposable loading units to reducethe overall costs associated with such procedures. It would also beparticularly beneficial if the device could perform multiple tasks,using disposable loading units of varying size and of varying purpose,such as, for example, to staple, clip, cut and/or articulate.

SUMMARY

In accordance with the present disclosure, improvements to a surgicalstapling apparatus for sequentially applying a plurality of fasteners tobody tissue and incising tissue are provided. In various embodiments, asurgical stapling apparatus includes a handle portion, an elongatedbody, or shaft, and a disposable loading unit, wherein the disposableloading unit is removably attachable to the elongated body. In at leastone embodiment, the elongated body can include a connector portion whichcan be operably engaged with a connector portion of the disposableloading unit such that, when a trigger of the handle portion isactuated, the trigger can advance a driver within the disposable loadingunit to deploy staples from the disposable loading unit and/or incisetissue. In previous surgical stapling devices, though, the disposableloading unit can become detached from the elongate body causing thesurgical stapling instrument to malfunction or be rendered inoperable.

In various embodiments of the present disclosure, such problems can beameliorated by utilizing a surgical stapling instrument having a handle,a shaft extending from the handle, wherein the shaft defines an axis,and a disposable loading unit which is assembled to the shaft in adirection which is transverse to the shaft axis. Such a connectionbetween the disposable loading unit and the shaft, in at least oneembodiment, can prevent, or at least inhibit, the disposable loadingunit from being unintentionally displaced proximally and/or distallyrelative to the shaft of the surgical instrument. In at least oneembodiment, the surgical stapling instrument and/or disposable loadingunit can further include a collar configured to threadably engage theshaft and/or a portion of the disposable loading unit. In variousembodiments, a disposable loading unit and/or elongated body can includea detent assembly for holding the disposable loading unit in place afterit has been assembled to the elongated body.

After a disposable loading unit has been attached to a surgical staplinginstrument, the instrument can be positioned relative to the soft tissueof a patient. In various circumstances, a surgical stapling instrumentcan include an anvil and a staple cartridge, where the anvil can berotated relative to the staple cartridge to position the anvil and thestaple cartridge with respect to the soft tissue. In some surgicalstapling instruments, the anvil can be configured to clamp the softtissue between the anvil and the staple cartridge as staples aredischarged from the staple cartridge. In various circumstances, aportion of the soft tissue can flow, or move, out of the distal end ofthe disposable loading unit and, as a result, the soft tissue may not beproperly treated by the surgical stapling instrument.

In various embodiments of the present disclosure, such problems can beameliorated by utilizing a surgical stapling instrument which can clampthe soft tissue, for example, prior to the staples being deployed fromthe staple cartridge. In various embodiments, a surgical staplinginstrument can include an actuator configured to be retracted relativeto the distal end of the disposable loading unit where the actuator canbe operably engaged with the anvil to rotate the anvil between an openposition and a closed position. In at least one embodiment, the actuatorcan include a cam, where the cam can include an arcuate profile havingan apex, and where the apex can be configured to be in contact with theanvil when the anvil is in a closed position. In at least one suchembodiment, the anvil can apply a clamping force to the soft tissueprior to the staples being deployed and prevent, or at least inhibit,the soft tissue from flowing, or ‘milking’, out of the distal end of thedisposable loading unit.

In various embodiments of the present disclosure, a surgical staplinginstrument can include a disposable loading unit comprising a staplecartridge, an anvil, and a sleeve, wherein the sleeve can be configuredto be slid relative to the staple cartridge and the anvil. In at leastone embodiment, the sleeve can include an aperture wherein the sleevecan be slid over at least a portion of the anvil and the staplecartridge to hold the anvil in a closed position. In at least one suchembodiment, the sleeve can be slid into position to apply a clampingforce to the soft tissue before staples are deployed into the softtissue. In various embodiments, a surgical stapling instrument caninclude a tongue configured to be slid relative to a staple cartridgeand an anvil, wherein the tongue can be configured to engage the anviland hold the anvil in a closed position. In at least one embodiment, thetongue can be configured such that it applies a force to the anvil at adistal end of the disposable loading unit so as to prevent, or at leastreduce, soft tissue from milking out of the distal end.

After the anvil has been moved into a closed position, a drive beam canbe advanced within the disposable loading unit to eject the staplestherefrom and/or incise the soft tissue. In various circumstances, theanvil can include a slot defined therein which can be configured toreceive at least a portion of the drive beam. In use, the drive beam canapply forces to the anvil which can cause the anvil to elasticallyand/or plastically deform and, as a result, affect the deployment of thesurgical staples into the soft tissue. In various embodiments of thepresent disclosure, an anvil can include a first member having staplepockets for deforming the staples, a first cover plate secured to thefirst member, and a second cover plate secured to at least one of thefirst member and the first cover plate, wherein the first and secondcover plates can be configured to support the first member. In at leastone embodiment, an anvil can include a first member inserted into asecond member, where the second member can be deformed such that thefirst member can be retained to and support the second member. In othervarious embodiments, the first member can be press-fit into the secondmember. In at least one embodiment, as a result of the above, the anvilcan be better configured to withstand the forces applied thereto andeliminate, or at least reduce, undesirable deflections within the anvil.

In various circumstances, especially during endoscopic surgicalprocedures, at least a portion of a surgical stapling instrument isinserted through a cannula, or trocar, into a surgical site. Often, ananvil of a disposable loading unit is moved into its closed positionbefore it is inserted into the trocar and then reopened after it hasbeen inserted therethrough. Some disposable loading units having largeanvils and/or staple cartridges may not fit, or easily fit, through thetrocar. In various embodiments of the present disclosure, a surgicalstapling instrument can include a disposable loading unit having ananvil which can be moved between open, closed, and/or collapsedpositions to facilitate the insertion of the disposable loading unitthrough the trocar. More particularly, in at least one embodiment, ananvil can be moved between a closed position in which the anvil is afirst distance away from the staple cartridge, for example, and acollapsed position in which the anvil is closer to the staple cartridgesuch that the disposable loading unit can be more easily insertedthrough the trocar.

After the disposable loading unit has been used, or expended, it can beremoved from the elongated body of the surgical instrument and a newdisposable loading unit can be assembled to the elongated body.Thereafter, the surgical instrument can be reinserted into a surgicalsite to perform additional steps of a surgical technique. In variouscircumstances, though, a surgeon, or other clinician, may becomeconfused as to whether a disposable loading unit has been previouslyexpended. In various embodiments of the present disclosure, a disposableloading unit can include a lockout feature which can prevent, or atleast inhibit, an expended disposable loading unit from beingreassembled to the elongated body of the surgical instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

Various preferred embodiments are described herein with reference to thedrawings:

FIG. 1 is a perspective view of one preferred embodiment of thepresently disclosed surgical stapling apparatus;

FIG. 2 is a top view of the surgical apparatus shown in FIG. 1;

FIG. 3 is a side view of the surgical apparatus shown in FIG. 1;

FIG. 4 is a perspective view with parts separated of the handle assemblyof the surgical apparatus shown in FIG. 1;

FIG. 5 is a cross-sectional view of a portion of the firing lockoutmechanism shown in FIG. 4;

FIG. 6 is a perspective of the slide plate of the anti-reverse clutchmechanism of the surgical apparatus;

FIG. 7 is an enlarged perspective view of the anti-reverse clutchmechanism shown in FIG. 1;

FIG. 8 is a side cross-sectional view of the surgical stapling apparatusshown in FIG. 1 in the non-actuated position with the disposable loadingunit removed;

FIG. 9 is a perspective view with parts separated of the rotationmember, the articulation mechanism, and the elongated body of thesurgical stapling apparatus shown in FIG. 1;

FIG. 10 is an enlarged view of the indicated area of detail shown inFIG. 8;

FIG. 10a is a perspective view of the translation member of thearticulating mechanism and the proximal end of the elongated body of thesurgical stapling apparatus shown in FIG. 1;

FIG. 10b is an enlarged cross-sectional view of the indicated area ofdetail of FIG. 8;

FIG. 10c is a cross-sectional view along section line 10 c-10 c of FIG.8;

FIG. 11 is a perspective view of the cam member of the articulationmechanism of the surgical stapling apparatus shown in FIG. 1;

FIG. 12 is a top view of the cam member of the articulation mechanism ofthe surgical stapling apparatus shown in FIG. 1;

FIG. 12a is a perspective view of a non-articulating disposable loadingunit usable with the surgical stapling apparatus shown in FIG. 1;

FIG. 12b is a perspective view of the preferred articulating disposableloading unit of the surgical stapling apparatus shown in FIG. 1;

FIG. 13 is a cross-sectional view taken along section line 13-13 of FIG.10;

FIG. 14 is a cross-sectional view taken along section line 14-14 of FIG.10;

FIG. 15 is a cross-sectional view taken along section line 15-15 of FIG.10;

FIG. 16 is an enlarged view of the indicated area of detail shown inFIG. 8;

FIG. 17 is a side perspective view of the blocking plate of the surgicalstapling apparatus shown in FIG. 1;

FIG. 18 is a top perspective view of the blocking plate of the surgicalstapling apparatus shown in FIG. 1;

FIG. 19 is a perspective view of a disposable loading unit usable withthe surgical stapling apparatus of FIG. 1;

FIG. 20 is another perspective view of a disposable loading unit usablewith the surgical stapling apparatus of FIG. 1;

FIG. 21 is a perspective view of the tool assembly of the surgicalstapling apparatus of FIG. 1 with parts separated;

FIG. 22 is an enlarged perspective view of the distal end of the anvilassembly showing a plurality of staple deforming cavities;

FIG. 23 is an enlarged perspective view of the distal end of the staplecartridge of the surgical stapling apparatus shown in FIG. 1;

FIG. 24 is a side cross-sectional view taken along section line 24-24 ofFIG. 23;

FIG. 25 is a bottom perspective view of the staple cartridge shown inFIG. 21;

FIG. 26 is an enlarged perspective view of the actuation sled, thepushers and the fasteners shown in FIG. 21;

FIG. 27 is an enlarged perspective view with parts separated of theproximal housing portion and mounting assembly of the disposable loadingunit shown in FIG. 19;

FIG. 28 is an enlarged perspective view of the mounting assembly of thedisposable loading unit shown in FIG. 19 mounted to a distal end portionof the proximal housing portion;

FIG. 29 is an enlarged perspective view of the proximal housing portionand the mounting assembly of the disposable loading unit shown in FIG.19 with the upper housing half removed;

FIG. 30 is a perspective view of the proximal housing portion and themounting assembly of the disposable loading unit shown in FIG. 19 withthe upper housing half removed;

FIG. 31 is a perspective view with parts separated of the axial driveassembly;

FIG. 32 is an enlarged perspective view of the axial drive assemblyshown in FIG. 31;

FIG. 33 is an enlarged perspective view of the proximal end of the axialdrive assembly shown in FIG. 31 including the locking device;

FIG. 34 is an enlarged perspective view of the distal end of the axialdrive assembly shown in FIG. 31;

FIG. 35 is an enlarged perspective view of the distal end of theelongated body of the stapling apparatus shown in FIG. 1;

FIG. 36 is an enlarged perspective view of the locking device shown inFIG. 33;

FIG. 37 is an enlarged perspective view of a lower housing half of theproximal housing portion of the disposable loading unit shown in FIG.27;

FIG. 38 is a side cross-sectional view of the disposable loading unitshown in FIG. 20;

FIG. 39 is an enlarged view of the indicated area of detail shown inFIG. 38;

FIG. 40 is a perspective view of the surgical stapling apparatus shownin FIG. 1 with the disposable loading unit of FIG. 19 detached from theelongated body;

FIG. 41 is an enlarged perspective view of the disposable loading unitof FIG. 19 during attachment to the elongated body of the surgicalstapling apparatus shown in FIG. 1;

FIG. 42 is another enlarged perspective view of the disposable loadingunit of FIG. 19 during attachment to the elongated body of the surgicalstapling apparatus shown in FIG. 1;

FIG. 43 is a cross-sectional view taken along section line 43-43 of FIG.41;

FIG. 43A is a side cross-sectional view of the rotation knob,articulation mechanism, and sensing mechanism during insertion of adisposable loading unit into the elongated body of the surgical staplingapparatus;

FIG. 44 is a cross-sectional view taken along section line 44-44 of FIG.42;

FIG. 45 is a side cross-sectional view of the distal end of thedisposable loading unit of FIG. 1 with tissue positioned between theanvil and clamp assemblies;

FIG. 46 is a side cross-sectional view of the handle assembly with themovable handle in an actuated position;

FIG. 47 is an enlarged view of the indicated area of detail shown inFIG. 46;

FIG. 48 is a cross-sectional view of the proximal end of the disposableloading unit of FIG. 19 and the distal end of the elongated body of thesurgical stapling apparatus shown in FIG. 1 with the control rod in apartially advanced position;

FIG. 49 is a cross-sectional view of the tool assembly of the surgicalstapling apparatus shown in FIG. 1 positioned about tissue in theclamped position;

FIG. 50 is a cross-sectional view of the handle assembly of the staplingapparatus of FIG. 1 during the clamping stroke of the apparatus;

FIG. 51 is a side cross-sectional view of the distal end of the toolassembly of the stapling apparatus shown in FIG. 1 during firing of theapparatus;

FIG. 52 is a side cross-sectional view of the distal end of the toolassembly of the stapling apparatus shown in FIG. 1 after firing of theapparatus;

FIG. 53 is a side cross-sectional view of the handle assembly of theapparatus during retraction of the actuation shaft;

FIG. 54 is a side cross-sectional view of the handle assembly of thestapling apparatus during actuation of the emergency release button;

FIG. 55 is a top view of the articulation mechanism of the surgicalstapling apparatus;

FIG. 56 is a side cross-sectional view of the articulation mechanism androtation member of the surgical stapling apparatus shown in FIG. 1;

FIG. 57 is a top view of the distal end of the elongated body, themounting assembly, and the proximal end of the tool assembly duringarticulation of the stapling apparatus;

FIG. 58 is a perspective view of the surgical stapling apparatus duringarticulation of the tool assembly;

FIG. 59 is a perspective view of the surgical stapling apparatus duringarticulation and rotation of the tool assembly;

FIG. 60 is a top view of the distal end of the disposable loading unitimmediately prior to articulation;

FIG. 61 is a top view of the distal end of the elongated body, themounting assembly, and the proximal end of the tool assembly duringarticulation of the stapling apparatus;

FIG. 62 is a partial cross-sectional view of a portion of the disposableloading unit during retraction of the locking device;

FIG. 63 is a partial cross-sectional view of a portion of the disposableloading unit with the locking device in the locked position;

FIG. 64 is a partial perspective view of an elongated body and adisposable loading unit of an embodiment of a surgical staplingapparatus;

FIG. 65 is a perspective view of an embodiment of a surgical staplingapparatus including an elongated body defining an axis and a disposableloading unit;

FIG. 66 is a perspective view of a connector portion of the disposableloading unit of FIG. 65 and a connector portion of the elongated body ofFIG. 65;

FIG. 67 is another perspective view of the connector portions of FIG. 66with additional components of the disposable loading unit removed;

FIG. 68 is a cross-sectional perspective view of the connector portionsof FIG. 66 assembled together and retained in position by a threadedcollar;

FIG. 69 is a cross-sectional elevational view of the connector portionsof FIG. 66 and the threaded collar of FIG. 68;

FIG. 70 is a cross-sectional view of a connector portion of a disposableloading unit assembled to a connector portion of an elongated body of analternative embodiment of a surgical stapling apparatus;

FIG. 71 is a detail view of the connector portions of FIG. 70;

FIG. 72 is a cross-sectional view of the surgical stapling apparatus ofFIG. 70 taken along line 72-72 in FIG. 71;

FIG. 73 is a detail view of an actuator of the elongated body of FIG.70;

FIG. 74 is a perspective view of a disposable loading unit of analternative embodiment of a surgical stapling apparatus;

FIG. 75 is an exploded view of the disposable loading unit of FIG. 74;

FIG. 76 is a cross-sectional view of the disposable loading unit of FIG.74 including an anvil in an open position;

FIG. 76A is a detail view of the disposable loading unit of FIG. 74illustrating an actuator operably engaged with the anvil;

FIG. 77 is a cross-sectional view of the disposable loading unit of FIG.74 illustrating the anvil in a closed position;

FIG. 77A is a detail view of the anvil and actuator of the disposableloading unit of FIG. 76A;

FIG. 78 is a plan view of the disposable loading unit of FIG. 74 withsome components removed;

FIG. 79 is a detail view of a portion of the disposable loading unit ofFIG. 74;

FIG. 80 is a bottom plan view of the disposable loading unit of FIG. 74;

FIG. 81 is a cross-sectional view of a staple cartridge carrier of thedisposable loading unit of FIG. 74;

FIG. 82 is a cross-sectional elevational view of an alternativeembodiment of a disposable loading unit with some components removed,the disposable loading unit including an anvil in an open position;

FIG. 83 is a detail view of the disposable loading unit of FIG. 82including an actuator for closing the anvil;

FIG. 84 is another cross-sectional elevational view of the disposableloading unit of FIG. 82 illustrating the anvil in a closed position;

FIG. 85 is a detail view of the actuator and the anvil of FIG. 83;

FIG. 86 is a perspective view of an anvil and an actuator of analternative embodiment of a disposable loading unit;

FIG. 87 is a perspective view of an actuator of a further alternativeembodiment of a disposable loading unit;

FIG. 88 is a perspective view of a drive beam of an alternativeembodiment of a disposable loading unit;

FIG. 89 is an end view of the drive beam of FIG. 88;

FIG. 90 is a cross-sectional view of a portion of the drive beam of FIG.88 positioned within a channel of an anvil;

FIG. 91 is a perspective view of a disposable loading unit of analternative embodiment of a surgical stapling apparatus;

FIG. 92 is an end view of the disposable loading unit of FIG. 91;

FIG. 93 is a cross-sectional view of the disposable loading unit of FIG.91;

FIG. 94 is a cross-sectional view of an alternative embodiment of adisposable loading unit;

FIG. 95 is a cross-sectional view of a further alternative embodiment ofa disposable loading unit;

FIG. 96 is a cross-sectional view of another alternative embodiment of adisposable loading unit;

FIG. 97 is a cross-sectional view of an alternative embodiment of adisposable loading unit;

FIG. 98 is a perspective view of an anvil assembly of an alternativeembodiment of a disposable loading unit, the anvil assembly including anouter portion and an insert portion;

FIG. 99 is a perspective view of the insert portion of FIG. 98;

FIG. 100 is a cross-sectional view of the insert positioned within theouter portion of the anvil assembly of FIG. 98;

FIG. 101 is a cross-sectional view of the anvil assembly of FIG. 98illustrating the outer portion after it has been deformed to retain theinsert portion therein;

FIG. 102 is a diagram of a piece of tubular stock having removedportions which are illustrated in dash;

FIG. 103 is a cross-sectional view of an anvil formed from the tubularstock of FIG. 102;

FIG. 104 is a cross-sectional view of an anvil assembly of analternative embodiment of a disposable loading unit, the anvil assemblyincluding an inner portion press-fit within an outer portion;

FIG. 105 is an end view of the inner portion of FIG. 104;

FIG. 106 is a cross-sectional view of an anvil assembly of analternative embodiment of a disposable loading unit, the anvil assemblyincluding a body and a support plate attached thereto;

FIG. 107 is a cross-sectional view of the anvil body of FIG. 106;

FIG. 108 is a cross-sectional view of the support plate of FIG. 106;

FIG. 109 is a perspective view of an alternative embodiment of adisposable loading unit including an anvil in a closed position and asleeve in a retracted position;

FIG. 110 is a perspective view of the disposable loading unit of FIG.109 illustrating the sleeve in an extended position to support theanvil;

FIG. 111 is a perspective view of an alternative embodiment of adisposable loading unit including an anvil in a closed position and atongue in a retracted position;

FIG. 112 is a perspective view of the disposable loading unit of FIG.111 illustrating the tongue in an extended position to support theanvil;

FIG. 113 is a cross-sectional view of the disposable loading unit ofFIG. 111;

FIG. 114 is an exploded view of an alternative embodiment of adisposable loading unit;

FIG. 115 is a cross-sectional view of the disposable loading unit ofFIG. 114 illustrating an anvil in an open position;

FIG. 116 is a detail view of the disposable loading unit of FIG. 114;

FIG. 117 is a cross-sectional view of the disposable loading unit ofFIG. 114 illustrating the anvil in a closed position;

FIG. 118 is a detail view of the disposable loading unit of FIG. 116;

FIG. 119 is a cross-sectional view of the disposable loading unit ofFIG. 114 illustrating the anvil in a collapsed position;

FIG. 120 is a detail view of the disposable loading unit of FIG. 114;

FIG. 121 is a cross-sectional view of the disposable loading unit ofFIG. 114 illustrating the anvil in its collapsed position;

FIG. 122 is a cross-sectional view of the disposable loading unit ofFIG. 114 illustrating the anvil returned to its closed position;

FIG. 123 is a perspective view of an alternative embodiment of adisposable loading unit;

FIG. 124 is a perspective view of a knife lockout of the disposableloading unit of FIG. 123;

FIG. 125 is a perspective view of the disposable loading unit of FIG.123 with some components removed and a connector portion of an elongatedbody of a surgical stapling apparatus;

FIG. 126 is another perspective view of the disposable loading unit ofFIG. 123;

FIG. 127 is another perspective view of the disposable loading unit ofFIG. 123 with some components of the elongated body connector portionremoved;

FIG. 128 is a perspective view of the disposable loading unit of FIG.123 prior to a drive beam of the surgical apparatus being advancedwithin the disposable loading unit and a retention plate engaged with abiasing spring;

FIG. 129 is a perspective view of the disposable loading unit of FIG.123 after the drive beam has been advanced the retention plate has beendisengaged from the biasing spring;

FIG. 130 is a perspective view of the disposable loading unit of FIG.123 after it has been disengaged from the connector portion of theelongated body illustrating the knife lockout biased into a locked-outposition by the biasing spring;

FIG. 131 is a perspective view of an alternative embodiment of adisposable loading unit;

FIG. 132 is an exploded view of the disposable loading unit of FIG. 131illustrating a removable staple cartridge;

FIG. 133 is an elevational view of the disposable loading unit of FIG.131;

FIG. 134 is an end view of the disposable loading unit of FIG. 131; and

FIG. 135 is another end view of the disposable loading unit of FIG. 131illustrating an anvil in an open position.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed endoscopic surgicalstapling apparatus will now be described in detail with reference to thedrawings, in which like reference numerals designate identical orcorresponding elements in each of the several views. Those of ordinaryskill in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments and that the scope ofthe various embodiments of the present invention is defined solely bythe claims. The features illustrated or described in connection with oneexemplary embodiment may be combined with the features of otherembodiments. Such modifications and variations are intended to beincluded within the scope of the present invention.

In the drawings and in the description that follows, the term“proximal”, as is traditional, will refer to the end of the staplingapparatus which is closest to the operator, while the term distal willrefer to the end of the apparatus which is furthest from the operator.

FIGS. 1-3 illustrate one embodiment of the presently disclosed surgicalstapling apparatus shown generally as 10. Briefly, surgical staplingapparatus 10 includes a handle assembly 12 and an elongated body 14. Adisposable loading unit or DLU 16 is releasably secured to a distal endof elongated body 14. Disposable loading unit 16 includes a toolassembly 17 having a cartridge assembly 18 housing a plurality ofsurgical staples and an anvil assembly 20 movably secured in relation tocartridge assembly 18. Disposable loading unit 16 is configured to applylinear rows of staples measuring from about 30 mm to about 60 mm inlength. Disposable loading units having linear rows of staples of otherlengths are also envisioned, e.g., 45 mm. Handle assembly 12 includes astationary handle member 22, a movable handle member 24, and a barrelportion 26. A rotatable member 28 is preferably mounted on the forwardend of barrel portion 26 to facilitate rotation of elongated body 14with respect to handle assembly 12. An articulation lever 30 is alsopreferably mounted on the forward end of barrel portion 26 adjacentrotatable knob 28 to facilitate articulation of tool assembly 17. A pairof retraction knobs 32 are movably positioned along barrel portion 26 toreturn surgical stapling apparatus 10 to a retracted position, as willbe described in detail below.

Referring to FIG. 4, handle assembly 12 includes housing 36, which ispreferably formed from molded housing half-sections 36 a and 36 b, whichforms stationary handle member 22 and barrel portion 26 of handleassembly 12 (See FIG. 1). Movable handle member 24 is pivotablysupported between housing half-sections 36 a and 36 b about pivot pin38. A biasing member 40, which is preferably a torsion spring, biasesmovable handle 24 away from stationary handle 22. An actuation shaft 46is supported within barrel portion 26 of housing 36 and includes atoothed rack 48. A driving pawl 42 having a rack engagement finger 43with laterally extending wings 43 a and 43 b is pivotably mounted to oneend of movable handle 24 about a pivot pin 44. A biasing member 50,which is also preferably a torsion spring, is positioned to urgeengagement finger 43 of driving pawl 42 towards toothed rack 48 ofactuation shaft 46. Movable handle 24 is pivotable to move engagementfinger 43 of driving pawl 42 into contact with toothed rack 48 ofactuation shaft 46 to advance the actuation shaft linearly in the distaldirection. The forward end of actuation shaft 46 rotatably receives theproximal end 49 of a control rod 52 such that linear advancement ofactuation shaft 46 causes corresponding linear advancement of controlrod 52. A locking pawl 54 having a rack engagement member 55 ispivotably mounted within housing 36 about pivot pin 57 and is biasedtowards toothed rack 48 by biasing member 56, which is also preferably atorsion spring. Engagement member 55 of locking pawl 54 is movable intoengagement with toothed rack 48 to retain actuation shaft 46 in alongitudinally fixed position.

A retraction mechanism 58 which includes a pair of retractor knobs 32(See FIG. 1) is connected to the proximal end of actuation shaft 46 by acoupling rod 60. Coupling rod 60 includes right and left engagementportions 62 a and 62 b for receiving retractor knobs 32 and a centralportion 62 c which is dimensioned and configured to translate within apair of longitudinal slots 34 a formed in actuation shaft 46 adjacentthe proximal end thereof. A release plate 64 is operatively associatedwith actuation shaft 46 and is mounted for movement with respect theretoin response to manipulation of retractor knobs 32. A pair of spacedapart pins 66 extend outwardly from a lateral face of actuation shaft 46to engage a pair of corresponding angled cam slots 68 formed in releaseplate 64. Upon rearward movement of retractor knobs 32, pins 66 canrelease plate 64 downwardly with respect to actuation shaft 46 and withrespect to toothed rack 48 such that the bottom portion of release plate64 extends below toothed rack 48 to disengage engagement finger 43 ofdriving pawl 42 from toothed rack 48. A transverse slot 70 is formed atthe proximal end of release plate 64 to accommodate the central portion62 c of coupling rod 60, and elongated slots 34 (See FIG. 1) are definedin the barrel section 26 of handle assembly 12 to accommodate thelongitudinal translation of coupling rod 60 as retraction knobs 32 arepulled rearwardly to retract actuation shaft 46 and thus retract controlrod 52 rearwardly. Actuation shaft 46 is biased proximally by spring 72which is secured at one end to coupling rod portion 62 via connector 74and at the other end to post 76 on actuation shaft 46.

Referring also to FIG. 5, handle assembly 12 includes a firing lockoutassembly 80 which includes a plunger 82 and a pivotable locking member83. Plunger 82 is biased to a central position by biasing springs 84 andincludes annular tapered camming surfaces 85. Each end of plunger 82extends through housing 36 (See FIG. 1) adjacent an upper end ofstationary handle 22. Pivotable locking member 83 is pivotably attachedat its distal end between housing half-sections 36 a and 36 b aboutpivot pin 86 and includes a locking surface 88 and proximal extension 90having a slot 89 formed therein. Locking member 83 is biased by spring92 counter-clockwise (as viewed in FIG. 4) to move locking surface 88 toa position to abut the distal end of actuation shaft 46 to preventadvancement of shaft 46 and subsequent firing of stapling apparatus 10.Annular tapered camming surface 85 is positioned to extend into taperedslot 89 in proximal extension 90. Lateral movement of plunger 82 ineither direction against the bias of either spring 84 moves taperedcamming surface 85 into engagement with the sidewalls of tapered slot 89to pivot locking member 83 clockwise about pivot pin 86, as viewed inFIG. 4, to move blocking surface 88 to a position to permit advancementof actuation shaft 46 and thus firing of stapling apparatus 10. Blockingsurface 88 is retained in this position by recesses 87 which receive thetapered tip of camming surface 85 to lock locking member 83 in acounter-clockwise position. Operation of firing lockout assembly 80 willbe further illustrated below.

Referring to FIGS. 4, 6, and 7, handle mechanism 12 also includes ananti-reverse clutch mechanism which includes a first gear 94 rotatablymounted on a first shaft 96, and second gear 98 mounted on a secondshaft 100, and a slide plate 102 (FIGS. 6 and 7) slidably mounted withinhousing 36. Slide plate 102 includes an elongated slot 104 dimensionedand configured to be slidably positioned about locking pawl pivot pin57, a gear plate 106 configured to mesh with the teeth of second gear98, and a cam surface 108. In the retracted position, cam surface 108 ofslide plate 102 engages locking pawl 54 to prevent locking pawl 54 fromengaging toothed rack 48. Actuation shaft 46 includes a distal set ofgear teeth 110 a spaced from a proximal set of gear teeth 110 bpositioned to engage first gear 94 of actuation shaft 46 during movementof actuation shaft 46. When actuation shaft 46 is advanced by pivotingmovable handle 24 about pivot pin 38, distal gear teeth 110 a onactuation shaft 46 mesh with and rotate first gear 94 and first shaft96. First shaft 96 is connected to second shaft 100 by spring clutchassembly such that rotation of first shaft 96 will cause correspondingrotation of second shaft 100. Rotation of second shaft 100 causescorresponding rotation of second gear 98 which is engaged with gearplate 106 on slide plate 102 to cause linear advancement of slide plate102. Linear advancement of slide plate 102 is limited to the length ofelongated slot 104. When slide plate has been advanced the length ofslot 104, cam surface 108 releases locking pawl 54 such that it is movedinto engagement with toothed rack 48. Continued advancement of actuationshaft 46 eventually moves gear teeth 110 b into engagement with gearplate 106. However, since slide plate 102 is longitudinally fixed inposition, the spring clutch is forced to release, such that continueddistal advancement of actuation shaft 46 is permitted.

When actuation shaft 46 is returned to the retracted position (bypulling retraction knobs 34 proximally, as discussed above) gear teeth110 b engage first gear 94 to rotate second gear 98 in the reversedirection to retract slide member 102 proximally within housing 36.Proximal movement of slide member 102 advances cam surface 108 intolocking pawl 54 prior to engagement between locking pawl 54 and toothedrack 48 to urge locking pawl 54 to a position to permit retraction ofactuation shaft 46.

Referring again to FIG. 4, handle assembly 12 includes an emergencyreturn button 112 pivotally mounted within housing 36 about a pivotmember 114 supported between housing half-sections 36 a and 36 b. Returnbutton 112 includes an externally positioned member 116 positioned onthe proximal end of barrel portion 26. Member 116 is movable about pivotmember 114 into engagement with the proximal end of locking pawl 54 tourge rack engagement member 55 out of engagement with toothed rack 48 topermit retraction of actuation shaft 46 during the firing stroke of thestapling apparatus 10. As discussed above, during the clamping portionof advancement of actuation shaft 46, slide plate 102 disengages pawl 54from rack 48 and thus actuation of return button 112 is not necessary toretract the actuation shaft 46.

FIG. 8 illustrates the interconnection of elongated body 14 and handleassembly 12. Referring to FIGS. 8-10, housing 36 includes an annularchannel 117 configured to receive an annular rib 118 formed on theproximal end of rotation member 28, which is preferably formed frommolded half-sections 28 a and 28 b. Annular channel 117 and rib 118permit relative rotation between rotation member 28 and housing 36.Elongated body 14 includes inner housing 122 and an outer casing 124.Inner housing 122 is dimensioned to be received within outer casing 124and includes an internal bore 126 (FIG. 8) which extends therethroughand is dimensioned to slidably receive a first articulation link 123 andcontrol rod 52. The proximal end of housing 122 and casing 124 eachinclude a pair of diametrically opposed openings 130 and 128,respectively, which are dimensioned to receive radial projections 132formed on the distal end of rotation member 28. Projections 132 andopenings 128 and 130 fixedly secure rotation member 28 and elongatedbody 14 in relation to each other, both longitudinally and rotatably.Rotation of rotation knob 28 with respect to handle assembly 12 thusresults in corresponding rotation of elongated body 14 with respect tohandle assembly 12.

An articulation mechanism 120 is supported on rotatable member 28 andincludes articulation lever 30, a cam member 136, a translation member138, and first articulation link 123 (FIG. 9). Articulation lever 30 ispivotably mounted about pivot member 140 which extends outwardly fromrotation member 28 and is preferably formed integrally therewith. Aprojection 142 extends downwardly from articulation lever 30 forengagement with cam member 136.

Referring temporarily to FIGS. 11 and 12, cam member 136 includes ahousing 144 having an elongated slot 146 extending through one sidethereof and a stepped camming surface 148 formed in the other sidethereof. Each step of camming surface 148 corresponds to a particulardegree of articulation of stapling apparatus 10. Although five steps areillustrated, fewer or more steps may be provided. Elongated slot 146 isconfigured to receive projection 142 formed on articulation lever 30.Housing 144 includes a distal stepped portion 150 and a proximal steppedportion 152. Proximal stepped portion 152 includes a recess 154.

Referring again to FIGS. 8-10 and also to FIGS. 13-15, translationmember 138 includes a plurality of ridges 156 which are configured to beslidably received within grooves 158 formed along the inner walls ofrotation member 28. Engagement between ridges 156 and grooves 158prevent relative rotation of rotation member 28 and translation member138 while permitting relative linear movement. The distal end oftranslation member 138 includes arm 160 which includes an opening 162configured to receive a finger 164 extending from the proximal end ofarticulation link 123 (See FIG. 10a ). A pin 166 having a housing 168constructed from a non-abrasive material, e.g., Teflon, is secured totranslation member 138 and dimensioned to be received within steppedcamming surface 148.

In an assembled condition, proximal and distal stepped portions 150 and152 of cam member 136 are positioned beneath flanges 170 and 172 formedon rotation member 28 to restrict cam member 136 to transverse movementwith respect to the longitudinal axis of stapling apparatus 10. Whenarticulation lever 30 is pivoted about pivot member 140, cam member 136is moved transversely on rotation member 28 to move stepped cammingsurface 148 transversely relative to pin 166, forcing pin 166 to moveproximally or distally along stepped cam surface 148. Since pin 166 isfixedly attached to translation member 138, translation member 138 ismoved proximally or distally to effect corresponding proximal or distalmovement of first actuation link 123.

Referring to FIGS. 8-10 and 16, a disposable loading unit sensingmechanism extends within stapling apparatus 10 from elongated body 14into handle assembly 12. The sensing mechanism includes a sensor tube176 which is slidably supported within bore 26 of elongated body 14. Thedistal end of sensor tube 176 is positioned towards the distal end ofelongated body 14 and the proximal end of sensor tube 176 is securedwithin the distal end of a sensor cylinder 176 via a pair of nubs 180.The distal end of a sensor link 182 is secured to the proximal end ofsensor cylinder 178. Sensor link 182 (See FIGS. 8a and 8c ) has abulbous end 184 which engages a camming surface 83 a on pivotablelocking member 83. When a disposable loading unit (not shown) isinserted in the distal end of elongated body 14, the disposable loadingunit engages the distal end 177 of sensor tube 176 to drive sensor tube176 proximally, and thereby drive sensor cylinder 178 and sensor link182 proximally. Movement of sensor link 182 proximally causes bulbousend 184 of sensor link 182 to move distally of camming surface 83 a toallow locking member 83 to pivot under the bias of spring 92 from aposition permitting firing of stapling apparatus 10 to a blockingposition, wherein blocking member 83 is positioned to engage actuationshaft 46 and prevent firing of stapling apparatus 10. Sensor link 182and locking member 83 function to prevent firing of surgical staplingapparatus 10 after a disposable loading unit has been secured toelongated body 14, without first operating firing lockout assembly 80.It is noted that movement of link 182 proximally permits locking member83 to move to its position shown in FIG. 5.

Referring again to FIGS. 9-12, cam member 136 includes recess 154. Alocking ring 184 having a nub portion 186 configured to be receivedwithin recess 154 is positioned about sensor cylinder 178 between acontrol tab portion 188 and a proximal flange portion 190. A spring 192positioned between flange portion 190 and locking ring 184 urges lockingring distally about sensor cylinder 178. When an articulating disposableloading unit 16 b having an extended insertion tip 193 is inserted intothe distal end of elongated body 14 of stapling apparatus 10, insertiontip 193 causes tab portion 188 to move proximally into engagement withlocking ring 184 to urge locking ring 184 and nub 186 proximally ofrecess 154 in cam member 136 (See FIG. 12b ). With nub 186 positionedproximally of recess 154, cam member 136 is free to move transversely toeffect articulation of stapling apparatus 10. A non-articulatingdisposable loading unit does not have an extended insertion tip (SeeFIG. 12a ). As such, when a non-articulating disposable loading unit isinserted in elongated body 14, sensor cylinder 178 is not retractedproximally a sufficient distance to move nub 186 from recess 154. Thus,cam member 136 is prevented from moving transversely by nub 186 oflocking ring 184 which is positioned in recess 154 and articulationlever 30 is locked in its central position.

Referring to FIGS. 16-18, the distal end of elongated body 14 includes acontrol rod locking mechanism 190 which is activated during insertion ofa disposable loading unit into elongated body 14. Control rod lockingmechanism 190 includes a blocking plate 192 which is biased distally bya spring 194 and includes a proximal finger 189 having angled camsurface 195. A semi-circular engagement member 196 is biasedtransversely towards control rod 52 by a spring 197. Control rod 52includes an annular recess 199 configured to receive engagement member196. Blocking plate 192 is movable from a distal position spaced fromengagement member 196 to a proximal position located behind engagementmember 196. In the proximal position, engagement member 196 is preventedfrom being biased from recess 199 by engagement with blocking plate 192.During insertion of a disposable loading unit 16 (See FIG. 1) into thedistal end of elongated body 14, as will be described in further detailbelow, cam surface 195 of blocking plate 192 is engaged by a nub 254(FIG. 30) on the disposable loading unit 16 as the disposable loadingunit is rotated into engagement with elongated body 14 to urge plate 192to the proximal position. Engagement member 196, which is positionedwithin recess 199, is retained therein by blocking plate 192 while nub254 engages cam surface 195 to prevent longitudinal movement of controlrod 52 during assembly. When the disposable loading unit 16 is properlypositioned with respect to the elongated body 14, nub 254 on theproximal end of the disposable loading unit 16 passes off cam surface195 allowing spring 194 to return blocking plate 192 to its distalposition to permit subsequent longitudinal movement of control rod 52.It is noted that when the disposable loading unit nub passes off camsurface 195, an audible clicking sound is produced indicating that thedisposable loading unit 16 is properly fastened to the elongated body14.

Referring to FIGS. 19 and 20, disposable loading unit 16 includes aproximal housing portion 200 adapted to releasably engage the distal endof body portion 14 (FIG. 1). A mounting assembly 202 is pivotallysecured to the distal end of housing portion 200, and is configured toreceive the proximal end of tool assembly 17 such that pivotal movementof mounting assembly 202 about an axis perpendicular to the longitudinalaxis of housing portion 200 effects articulation of tool assembly 17.

Referring to FIGS. 21-26, tool assembly 17 preferably includes anvilassembly 20 and cartridge assembly 18. Anvil assembly 20 includes anvilportion 204 having a plurality of staple deforming concavities 206 (FIG.22) and a cover plate 208 secured to a top surface of anvil portion 204to define a cavity 210 (FIG. 24) therebetween. Cover plate 208 isprovided to prevent pinching of tissue during clamping and firing ofstapling apparatus 10. Cavity 210 is dimensioned to receive a distal endof an axial drive assembly 212 (See FIG. 27). A longitudinal slot 214extends through anvil portion 204 to facilitate passage of retentionflange 284 of axial drive assembly 212 into the anvil cavity 210. Acamming surface 209 formed on anvil portion 204 is positioned to engageaxial drive assembly 212 to facilitate clamping of tissue 198. A pair ofpivot members 211 formed on anvil portion 204 are positioned withinslots 213 formed in carrier 216 to guide the anvil portion between theopen and clamped positions. A pair of stabilizing members 215 engage arespective shoulder 217 formed on carrier 216 to prevent anvil portion204 from sliding axially relative to staple cartridge 220 as cammingsurface 209 is deformed.

Cartridge assembly 18 includes a carrier 216 which defines an elongatedsupport channel 218. Elongated support channel 218 is dimensioned andconfigured to receive a staple cartridge 220. Corresponding tabs 222 andslots 224 formed along staple cartridge 220 and elongated supportchannel 218 function to retain staple cartridge 220 within supportchannel 218. A pair of support struts 223 formed on staple cartridge 220are positioned to rest on side walls of carrier 216 to further stabilizestaple cartridge 220 within support channel 218.

Staple cartridge 220 includes retention slots 225 for receiving aplurality of fasteners 226 and pushers 228. A plurality of spaced apartlongitudinal slots 230 extend through staple cartridge 220 toaccommodate upstanding cam wedges 232 of actuation sled 234. A centrallongitudinal slot 282 extends along the length of staple cartridge 220to facilitate passage of a knife blade 280. During operation of surgicalstapler 10, actuation sled 234 translates through longitudinal slots 230of staple cartridge 220 to advance cam wedges 232 into sequentialcontact with pushers 228, to cause pushers 228 to translate verticallywithin slots 224 and urge fasteners 226 from slots 224 into the stapledeforming cavities 206 of anvil assembly 20.

Referring to FIGS. 27 and 28, mounting assembly 202 includes upper andlower mounting portions 236 and 238. Each mounting portion includes athreaded bore 240 on each side thereof dimensioned to receive threadedbolts 242 (See FIG. 21) for securing the proximal end of carrier 216thereto. A pair of centrally located pivot members 244 (See FIG. 21)extends between upper and lower mounting portions via a pair of couplingmembers 246 which engage the distal end of housing portion 200. Couplingmembers 246 each include an interlocking proximal portion 248 configuredto be received in grooves 250 formed in the proximal end of housingportion 200 to retain mounting assembly 202 and housing portion 200 in alongitudinally fixed position in relation thereto.

Housing portion 200 of disposable loading unit 16 includes an upperhousing half 250 and a lower housing half 252 contained within an outercasing 251. The proximal end of housing half 250 includes engagementnubs 254 for releasably engaging elongated body 14 and an insertion tip193. Nubs 254 form a bayonet type coupling with the distal end of body14 which will be discussed in further detail below. Housing halves 250and 252 define a channel 253 for slidably receiving axial drive assembly212. A second articulation link 256 is dimensioned to be slidablypositioned within a slot 258 formed between housing halves 250 and 252.A pair of blow out plates 254 are positioned adjacent the distal end ofhousing portion 200 adjacent the distal end of axial drive assembly 212to prevent outward bulging of drive assembly 212 during articulation oftool assembly 17.

Referring to FIGS. 29-30, second articulation link 256 includes at leastone elongated metallic plate. Preferably, two or more metallic platesare stacked to form link 256. The proximal end of articulation link 256includes a hook portion 258 configured to engage first articulation link123 (See FIG. 9) and the distal end includes a loop 260 dimensioned toengage a projection 262 formed on mounting assembly 202. Projection 262is laterally offset from pivot pin 244 such that linear movement ofsecond articulation link 256 causes mounting assembly 202 to pivot aboutpivot pins 244 to articulate tool assembly 17.

Referring also to FIGS. 31-34, axial drive assembly 212 includes anelongated drive beam 266 including a distal working head 268 and aproximal engagement section 270. Drive beam 266 may be constructed froma single sheet of material or, preferably, multiple stacked sheets.Engagement section 270 includes a pair of engagement fingers 270 a and270 b which are dimensioned and configured to mountingly engage a pairof corresponding retention slots 272 a and 272 b formed in drive member272. Drive member 272 includes a proximal porthole 274 configured toreceive the distal end 276 of control rod 52 (See FIG. 35) when theproximal end of disposable loading unit 16 is engaged with elongatedbody 14 of surgical stapling apparatus 10.

The distal end of drive beam 266 is defined by a vertical support strut278 which supports a knife blade 280, and an abutment surface 283 whichengages the central portion of actuation sled 234 during a staplingprocedure. Surface 285 at the base of surface 283 is configured toreceive a support member 287 slidably positioned along the bottom of thestaple cartridge 220. Knife blade 280 is positioned to translateslightly behind actuation sled 234 through a central longitudinal slot282 in staple cartridge 220 (FIG. 30) to form an incision between rowsof stapled body tissue. A retention flange 284 projects distally fromvertical strut 278 and supports a cylindrical cam roller 286 at itsdistal end. Cam roller 286 is dimensioned and configured to engage camsurface 209 on anvil body 204 to clamp anvil portion 204 against bodytissue.

Referring also to FIGS. 36-39, a locking device 288 is pivotally securedto drive member 270 about a pivot pin 290. Locking device 288 includes apair of elongate glides 292 and 294 which define a channel 296. A web298 joins a portion of the upper surfaces of glides 292 and 294, and isconfigured and dimensioned to fit within elongated slot 298 formed indrive beam 266 at a position distal of drive member 270. Horizontal cams300 and 302 extend from glides 292 and 294 respectively, and areaccommodated along an inner surface of lower housing half 252. As bestshown in FIG. 42, a torsion spring 304 is positioned adjacent drivemember 270 and engages horizontal cams 300 and 302 of locking device 288to normally bias locking device 288 downward toward lower housing half252 onto ledge 310. Locking device 288 translates through housingportion 200 with axial drive assembly 212. Operation of locking device288 will be described below.

Sequence of Operation

Referring to FIGS. 40-44, to use stapling instrument 10, a disposableloading unit 16 is first secured to the distal end of elongated body 14.As discussed above, stapling instrument 10 can be used with articulatingand non-articulating disposable loading units having linear rows ofstaples between about 30 mm and about 60 mm. To secure disposableloading unit 16 to elongated body 14, the distal end 276 of control rod52 is inserted into insertion tip 193 of disposable loading unit 16, andinsertion tip 193 is slid longitudinally into the distal end ofelongated body 14 in the direction indicated by arrow “A” in FIG. 41such that hook portion 258 of second articulation link 256 slides withina channel 310 in elongated body 314. Nubs 254 will each be aligned in arespective channel (not shown) in elongated body 14. When hook portion258 engages the proximal wall 312 of channel 310, disposable loadingunit 16 is rotated in the direction indicated by arrow “B” in FIGS.41-44 to move hook portion 258 of second articulation link 256 intoengagement with finger 164 of first articulation link 123. Nubs 254 alsoforms a bayonet type coupling within annular channel 314 in body 14.During rotation of loading unit 16, nubs 254 engage cam surface 195(FIG. 41) of block plate 192 to initially move plate 192 in thedirection indicated by arrow “C” in FIGS. 41 and 43 to lock engagementmember 196 in recess 199 of control rod 52 to prevent longitudinalmovement of control rod 52 during attachment of disposable loading unit16. During the final degree of rotation, nubs 254 disengage from camsurface 195 to allow blocking plate 192 to move in the directionindicated by arrow “D” in FIGS. 42 and 44 from behind engagement member196 to once again permit longitudinal movement of control rod 52.

Referring to FIGS. 43 and 43 a, when insertion tip 193 engages thedistal end of sensor tube 176, the disposable loading unit sensingmechanism is actuated. Insertion tip 193 engages and moves sensor tube176 proximally in the direction indicated by arrow “E” in FIG. 43. Asdiscussed above, proximal movement of sensor tube 176 effects proximalmovement of sensor cylinder 178 and sensor link 182 in the directionindicated by arrow “E” in FIG. 43a to pivot locking member 83counter-clockwise, as indicated by arrow “Y” in FIG. 43a , from anon-blocking position to a position blocking movement of actuation shaft46.

Referring to FIGS. 46-49, with a disposable loading unit attached tostapling instrument 10, tool assembly 17 can be positioned about tissue320 (FIG. 45). To clamp tissue between anvil assembly 20 and cartridgeassembly 18, stationary handle 24 is moved in the direction indicated byarrow “E” in FIG. 46 against the bias of torsion spring 40 to movedriving pawl 42 into engagement with shoulder 322 on actuation shaft 46.Engagement between shoulder 322 and driving pawl 42 advances actuationshaft 46 and thus advances control rod 52 distally. Control rod 52 isconnected at its distal end to axial drive assembly 212 (FIG. 48),including drive beam 266, such that distal movement of control rod 52effects distal movement of drive beam 266 in the direction indicated byarrow “F” in FIGS. 48 and 49, moving cam roller 286 into engagement withcam surface 209 on anvil portion 204 to urge anvil portion 204 in thedirection indicated by arrow “G” in FIG. 49. It is noted that onecomplete stroke of movable handle 24 advances actuation shaft 46approximately 15 mm which is sufficient to clamp tissue during the firststroke but not to fire staples.

As discussed above with respect to the anti-reverse clutch mechanism,during the first (clamping) stroke of movable handle 24, slide plate 102(FIG. 46) prevents locking pawl 54 from engaging toothed rack 48. Tomaintain actuation shaft 46 in its longitudinal position after handle 24is released, an engagement member 324 (FIG. 47) is provided on lockingmember 83 to engage shoulder 326 on actuation shaft 46 and retain shaft46 in its longitudinal position (See FIG. 47). Upon release of movablehandle 24, drive pawl 42 moves over rack 48 as torsion spring 40 returnshandle 24 to a position spaced from stationary handle 22. In thisposition, driving pawl 42 is urged into engagement with toothed rack 48to retain actuation shaft 46 in its longitudinal fixed position.

In order to fire staples, movable handle 24 is actuated again, i.e.,moved through another stroke. As discussed above, stapling apparatus 10is capable of receiving disposable loading units having linear rows ofstaples of between about 30 mm and about 60 mm. Since each stroke of themovable handle 24 preferably advances actuation shaft 46 15 mm, and onestroke is required to clamp tissue, the movable handle must be actuated(n+1) strokes to fire staples, where n is the length of the linear rowsof staples in the disposable loading unit attached to staplinginstrument 10 divided by 15 mm.

Referring to FIG. 50, prior to being able to fire staples, firinglockout assembly 80 (FIG. 4) must be actuated to move locking surface 88from its blocking position (FIG. 47) to a non-blocking position. This isaccomplished by pressing down on plunger 82 to move camming surface 85into engagement with sidewalls of slot 89 of locking member 83 to pivotlocking member 83 in the direction indicated by arrow “G” in FIG. 50(see also FIG. 5). Thereafter, movable handle 24 may be actuated anappropriate number of strokes to advance actuation shaft 46, and thuscontrol rod 52 and drive beam 266, distally in the direction indicatedby arrow “H” in FIGS. 51 and 52 to advance actuation sled 234 throughstaple cartridge 220 to effect ejection of staples. It is noted thatafter the first or clamping stroke of movable handle 54 (during thesecond stroke), slide 102 passes over locking pawl 54 allowing torsionspring 56 to move locking pawl 54 in the direction indicated by arrow“I” in FIG. 50 into engagement with toothed rack 48 to retain actuationshaft 46 in its longitudinal position.

Referring to FIG. 53, to retract actuation shaft 46 and thus control rod52 and drive member 266 after firing staples, retraction knobs 32 (seeFIG. 1) are pulled proximally causing pins 66 to move release plate 64in the direction indicated by arrow “J” in FIG. 53 over teeth 48 todisengage drive pawl 42 from engagement with teeth 48. As discussedabove, with respect to the anti-reverse clutch mechanism, locking pawl54 is urged by slide plate 102 out of engagement with toothed rack 48(not shown) to permit actuation shaft 46 to be moved proximally, in thedirection indicated by arrow “L”, after drive pawl 42 is disengaged fromteeth 48.

Referring to FIG. 54, in order to retract actuation shaft 46 prior tofiring stapling apparatus, i.e., when locking pawl is currently engagedwith toothed racked 48, emergency return button 112 is pushed in thedirection indicated by arrow “Z” in FIG. 54 to disengage locking pawl 54from toothed rack 48. Retraction knobs 32 (FIG. 1) must also beconcurrently pulled rearwardly, as discussed above, to release drivepawl 42 from rack 48.

Referring to FIGS. 55-61, when an articulating disposable loading unitis secured to elongated body 14 and articulation lever 30 is pivoted inthe direction indicated by arrow “M” in FIG. 55, cam member 136 is movedtransversely by projection 142 (FIG. 10) in the direction indicated byarrow “N” between flanges 170 and 172 of rotation knob 28. Sincetranslation member 138 is prevented from rotating by ridges 156 (FIG.13), pin 166, which is fixedly secured to translation member 138, isforced to move along stepped cam surface 148. Movement of pin 166 causescorresponding movement of translation member 138 in the directionindicated by arrow “P” in FIGS. 55 and 56 to advance first articulationlink 123 in the distal direction. The distal end of first articulationlink 123 engages the proximal end of second articulation link 256 (FIG.42) which is connected to projection 262 on mounting assembly 202 toadvance second link 256 in the direction indicated by arrow “Q” in FIG.57. Projection 262 is laterally offset from pivot members 244, such thatdistal advancement of second articulation link 256 causes mountingassembly 202 and thus tool assembly 17 to pivot in the directionindicated by arrow “R” in FIGS. 57 and 58. Note in FIG. 59 that rotationmember 28 can be rotated to rotate elongated body 14 about itslongitudinal axis while tool assembly 17 is articulated.

FIGS. 60-61 illustrate articulation of tool assembly 17 in the oppositedirection to that described above. When second articulation link 256 isretracted by rotating articulation lever 30 in a counter-clockwisedirection (not shown) as viewed in FIG. 55, pin 66 is forced to moveproximally along stepped camming surface 148, moving translation member138 and first articulation link 123 proximally. Movement of firstarticulation link 123 proximally, causes second articulation link 256 tomove proximally as indicated by arrow “S” in FIG. 58, to rotate toolassembly 17 in a clockwise direction, as indicated by arrow “T” in FIG.61.

Referring to FIG. 12, movement of pin 166 (FIG. 9) between adjacent stepportions 340 causes tool assembly 17 to articulate 22.5 degrees. Cammingsurface 148 includes five step portions 340. The third step portioncorresponds to the non-articulated tool assembly position, whereas thefirst and the fifth step portions correspond to articulation of toolassembly 17 to forty-five degrees. Each step portion is flat to retainarticulation lever 30 in a fixed position when pin 166 is engagedtherewith.

Referring now to FIGS. 37, 39, 62 and 63, the sequence of lockoutoperation will be described in detail. In FIG. 39, lockout device 288 isshown in its prefired position with horizontal cams 300 and 302 restingon top of projections 330 formed in the sidewalls of lower housing half252 (FIG. 37). In this position, locking device 288 is held up out ofalignment with projection 332 formed in the bottom surface of lowerhousing half 252, and web 298 is in longitudinal juxtaposition withshelf 334 defined in drive beam 266. This configuration permits theanvil 20 (FIG. 38) to be opened and repositioned onto the tissue to bestapled until the surgeon is satisfied with the position withoutactivating locking device 288 to disable the disposable loading unit 16.

As shown in FIG. 62, upon distal movement of drive beam 266, lockingdevice 288 rides off of projections 330 (not shown) and is biased intoengagement with base lower housing half 252 by spring 304, distal toprojection 332. Locking device 288 remains in this configurationthroughout firing of the apparatus.

Upon retraction of the drive beam 266 in the direction indicated byarrow “U” in FIG. 62, locking device 288 passes under projections 330and rides over projection 332 until the distalmost portion of lockingdevice 288 is proximal to projection 332. Spring 304 biases lockingdevice 288 into juxtaposed alignment with projection 332, effectivelydisabling the disposable loading unit. If an attempt is made toreactuate the apparatus, the control rod 52 will abut a proximal endsurface of locking device 288 which surface is diagonally sloped toimpart a moment about pivot pin 342 such that the distal end of lockingdevice 288 is rotationally urged into contact with projection 332.Continued distal force in the direction indicated by arrow “W” in FIG.63, will only serve to increase the moment applied to the locking devicethus the locking device will abut projection 332 and inhibit distalmovement of the control rod 52.

Referring again to FIGS. 41-44, the disabled or locked disposableloading unit can be removed from the distal end of elongated body 14 byrotating disposable loading unit 16 in the direction opposite to thedirection indicated by arrow “B” in FIGS. 41, 42 and 44, to disengagehook portion 258 of second articulation link 256 from finger 164 offirst articulation link 123, and to disengage nubs 254 from withinchannel 314 of elongated body 14. After rotation, disposable loadingunit 16 can be slid in the direction opposite to that indicated by arrow“A” in FIG. 41 to detach body 14 from disposable loading unit 16.Subsequently, additional articulating and/or non-articulating disposableloading units can be secured to the distal end of elongated body, asdescribed above, to perform additional surgical stapling and/or cuttingprocedures. As discussed above, each disposable loading unit may includelinear rows of staples which vary from about 30 mm to about 60 mm.

Although the above-described surgical stapling instruments may besuitable for their intended purpose, improvements to these instrumentsare provided below. As described above, surgical stapling instrumentscan include a handle portion, an elongated body, or shaft, and adisposable loading unit, wherein the disposable loading unit can beremovably attached to the elongated body. As described above inconnection with disposable loading unit 16 illustrated in FIGS. 40-42,elongated body 14 of the surgical stapling instrument can define an axisalong which disposable loading unit 16 can be assembled thereto. Invarious circumstances, though, disposable loading unit 16 can becomeunintentionally detached from elongated body 14 causing the surgicalstapling instrument to malfunction or be rendered inoperable. Suchcircumstances can particularly arise when the disposable loading unitbecomes detached and separated from the elongated body along the axisdefined by the elongated body, i.e., the axis along which the disposableloading unit was assembled to the elongated body. In various embodimentsof the present invention, a disposable loading unit can be assembled toan elongated body of a surgical instrument in a direction which is notcollinear with or parallel to the elongated body axis. In at least oneembodiment, referring to FIG. 65, disposable loading unit 1016 can beassembled to elongated body 1014 in a direction which is transverse,perpendicular, or oblique to axis 1015 defined by elongated body 1014.

In various embodiments, referring to FIGS. 66 and 67, disposable loadingunit 1016 can include connector portion 1017 which can be configured tobe engaged with connector portion 1019 of elongated body 1014. In atleast one embodiment, connector portion 1017 can include at least oneprojection and/or groove which can be mated with at least one projectionand/or groove of connector portion 1019. In at least one suchembodiment, the connector portions can include co-operating dovetailportions. In various embodiments, the connector portions can beconfigured to interlock with one another and prevent, or at leastinhibit, distal and/or proximal movement of disposable loading unit 1016along axis 1015. In at least one embodiment, similar to the devicesdescribed above, the surgical stapling instrument can include controlrod 1052 which can be operably connected to drive member 1212 ofdisposable loading unit 1016 such that drive member 1212 can be advanceddistally to deploy staples therefrom and/or incise tissue, for example,upon an actuation of handle member 24 (FIG. 1). In at least one suchembodiment, drive member 1212 can include aperture 1272 which can beconfigured to receive projection 1276 extending from control rod 1052.In various embodiments, such an arrangement can allow disposable loadingunit 1016 to be assembled to elongated member 1014 in a direction whichis not collinear with or parallel to axis 1015. Although notillustrated, drive member 1212 and control rod 1052 can include anyother suitable arrangement of projections and apertures to operablyconnect them to each other. Also similar to the devices described above,the surgical instrument can include first articulation link 1123 whichcan be operably engaged with second articulation link 1256 such that theoperation of articulation lever 1030 can be transmitted to disposableloading unit 1016.

In various embodiments, further to the above, the projections and/orgrooves of connector portions 1017 and 1019 can be configured such thatthey can be press-fit together to prevent, or at least inhibit,disposable loading unit 1016 from moving in a direction which istransverse to axis 1015. In at least one embodiment, referring primarilyto FIGS. 68 and 69, a sleeve, or collar, can be utilized to retain thedisposable loading unit to the elongated member. In various embodiments,collar 1021 can be threadably engaged with threaded portion 1023 ofdisposable loading unit 1016 to prevent connector portions 1017 and 1019from being disengaged from one another. In at least one embodiment,collar 1021 can include aperture 1025 having, first, a threaded portion1027 which can threadably engage threaded portion 1023 and, second, asecond portion 1029 which can closely receive elongated member 1014 soas to prevent, or at least limit, relative movement between disposableloading unit 1016 and elongated member 1014. Alternatively, although notillustrated, a collar can be configured to threadably engage elongatedmember 1014 and closely receive disposable loading unit 1016. In atleast one embodiment, a collar can be configured to threadably engageboth the elongated member and the disposable loading unit.

In various embodiments, a detent mechanism can be utilized to retain adisposable loading unit to an elongated member of a surgical staplinginstrument. In at least one embodiment, referring to FIGS. 70-72,elongated member 2014 can include at least one ball detent 2031 whichcan be configured to engage disposable loading unit 2016 and holddisposable loading unit 2016 in position. In various embodiments,elongated member can include at least one aperture 2033 for receivingball detents 2031 and at least one retention member 2035 for retainingball detents 2031 in apertures 2033. In at least one embodiment,retention members 2035 can also be configured to bias ball detents 2031into recesses 2037 in disposable loading unit 2016 such that themovement of disposable loading unit 2016 along axis 2015 can beprevented, or at least inhibited. In use, insertion tip 2193 ofdisposable loading unit 2016 can be inserted into elongated member 2014such that the end of disposable loading unit 2016 can contact balldetents 2031 and displace them radially within apertures 2033. Oncedisposable loading unit 2016 has been inserted to its proper depth,recesses 2037 can be substantially aligned with apertures 2033 andretention members 2035 can position at least a portion of ball detentswithin recesses 2037.

In various embodiments, further to the above, at least one of retentionmembers 2035 can be comprised of a resilient material. In at least oneembodiment, ball detents 2031 and retention members 2035 can bestructured and arranged such that retention members 2035 are deflectedoutwardly by ball detents 2031 and, as a result, resilient members 2035can apply a biasing force to ball detents 2031. In order to releasedisposable loading unit 2016 from elongated member 2014, elongatedmember 2016 can further include actuator 2039 which can be manipulatedto retract retention members 2035 proximally such that undercut 2041 ofresilient members 2035 can be aligned, or at least substantiallyaligned, with ball detents 2031. In various embodiments, the alignmentof undercut 2041 with ball detents 2031 can allow ball detents 2031 tobe displaced radially and out of engagement with recesses 2037 whendisposable loading unit 2016 is pulled out of the aperture in elongatedmember 2014. In at least one embodiment, referring to FIGS. 70 and 73,elongated member 2014 can further include return spring 2043 which canbe configured to advance actuator 2039 and retention members 2035distally and reposition retention members 2035 relative to ball detents2031. In various embodiments, as illustrated in FIGS. 71 and 72, balldetents 2031 can be spherical, or at least substantially spherical, andcan be comprised of any suitable material such as stainless steel, forexample. In other various embodiments, although not illustrated, detents2031 can have any suitable non-spherical shape.

In various embodiments, a disposable loading unit and an elongatedmember of a surgical instrument can include co-operating snap-fitfeatures for retaining the disposable loading unit to the surgicalstapling instrument. In at least one embodiment, although notillustrated, a disposable loading unit can include arms extendingtherefrom which can be at least partially received within apertures orrecess in an elongated assembly. In use, the arms can be configured toflex inwardly toward each other as they are inserted into the elongatedmember and then resiliently spring outwardly when the arms are alignedwith the apertures. In various embodiments, the surgical instrument caninclude a lock which can be slid intermediate the arms to hold the armsin the apertures and prevent, or at least inhibit, the disposableloading unit from becoming detached from the surgical instrument. In atleast one embodiment, the lock could be slid distally upon an actuationof a trigger. In various alternative embodiments, the lock can includeone or more cams configured to engage the arms and retain them in theapertures when the lock is rotated.

After a disposable loading unit has been attached to a surgical staplinginstrument, the instrument can be positioned relative to the soft tissueof a patient. In various circumstances, a surgical stapling instrumentcan include an anvil and a staple cartridge, where the anvil can berotated relative to the staple cartridge to position the anvil and thestaple cartridge with respect to the soft tissue. As described above inconnection with disposable loading unit 16 illustrated in FIGS. 38 and40, disposable loading unit 16 can include anvil assembly 20 andcartridge assembly 18, where anvil assembly 20 can be pivoted between anopen and closed positions. In some such devices, as outlined above andreferring to FIG. 24, axial drive assembly 212 can be configured tocontact camming surface 209 of anvil assembly 20 and move anvil assembly20 into a closed position upon a first actuation of movable handle 24.Upon subsequent actuations of movable handle 24, drive assembly 212 canbe advanced through disposable loading unit 16 to clamp, staple, andincise the soft tissue positioned intermediate cartridge assembly 18 andanvil assembly 20. In such instruments, as a result of the tissue beingclamped at the same time as it is being stapled and incised, a portionof the soft tissue can flow, or ‘milk’, out of the distal end of thedisposable loading unit and, in various circumstances, the soft tissuemay not be properly treated by the surgical stapling instrument.

In various embodiments of the present invention, such problems can beameliorated by utilizing a surgical stapling instrument which can applya clamping force to soft tissue prior to the staples being deployed fromthe staple cartridge and/or the drive assembly being advanced within thedisposable loading unit. In various circumstances, such embodiments canprevent, or at least inhibit, the soft tissue from milking out of thedistal end of the disposable loading unit. In at least one embodiment, asurgical stapling instrument can include an actuator configured to beretracted relative to the distal end of the disposable loading unit torotate the anvil between an open position and a closed position andclamp the tissue in position. In at least one such embodiment, referringto FIGS. 74-81, disposable loading unit 3016 can include cartridgeassembly 3018 and anvil assembly 3020, where anvil assembly 3020 can berotated toward cartridge assembly 3018 by actuator 3043. In at least oneembodiment, anvil assembly 3020 can include, first, at least one pivottab 3211 which can be rotatably received within an aperture or recesswithin staple cartridge assembly 3018, for example, and, second, atleast one recess 3047 which can be configured to operably receive atleast a portion of actuator 3043. When actuator 3043 is pulled in adirection indicated by arrow “P”, in at least one embodiment, actuator3043 can rotate anvil assembly 3020 into a closed position about an axisdefined by pivot tabs 3211 and apply a clamping force to the softtissue.

In various embodiments, as outlined above, actuator 3043 can include atleast one projection 3049 which can be configured to engage thesidewalls of recess 3047 and apply a force to anvil assembly 3020. In atleast one embodiment, such a force can generate a torque, orforce-moment, causing anvil assembly 3020 to rotate about pivot tabs3211 between an open position, as illustrated in FIG. 76, and a closedposition, as illustrated in FIG. 77. In use, as also outlined above,such a torque can apply a clamping pressure or force to tissuepositioned intermediate anvil assembly 3020 and staple cartridgeassembly 3018. In various embodiments, the torque applied to anvilassembly 3020 can be directly proportional to the force applied byactuator 3043 and the distance between projections 3049 and pivot tabs3211, i.e., distance “D” (FIG. 77). In at least one embodiment, adisposable loading unit can be designed such that distance D can bemaximized, or at least substantially increased, to apply a largerclamping moment or force to the soft tissue. In at least one suchembodiment, referring to FIGS. 80 and 81, staple cartridge assembly 3018can comprise staple cartridge carrier 3216 which can include apertures,or recesses, 3045 which can be configured to allow at least a portion ofprojections 3049 to extend therethrough such that the distance betweenprojections 3049 and pivot tabs 3211 can be increased.

In various embodiments, referring to FIG. 75, disposable loading unit3016 can include spring 3051 which can configured to bias anvil assembly3020 into an open position and, in addition, a spring which can biasactuator 3043 into its most distal position. In use, as outlined above,actuator 3043 can be pulled proximally to pivot anvil assembly 3020 intoits closed position. In such circumstances, as illustrated in FIG. 77A,anvil assembly 3020 can resiliently compress spring 3051 such thatspring 3051 can return anvil assembly 3020 to its open position whenactuator 3043 is released as described in greater detail below. Invarious embodiments, a surgical instrument can include a trigger, or anyother suitable actuation device, which can be manipulated by a surgeon,or other clinician, to pull actuator 3043 proximally and, in at leastone embodiment, lock actuator 3043 in its retracted position. In atleast one embodiment, referring generally to FIGS. 1 and 9, actuator3043 can be operably engaged with articulation lever 30 and firstarticulation link 123 such that, when articulation lever 30 is rotatedin a first direction, articulation link 123 and actuator 3043 can beretracted proximally. Similarly, when articulation lever 30 is rotatedin a second direction, articulation link 123 and actuator 3043 can beadvanced distally. In various embodiments, actuator 3043 can be advanceddistally to remove projections 3049 from recesses 3047 and allow spring3051 to return anvil assembly 3020 to its open position.

In various embodiments, a disposable loading unit can include anactuator comprising a cam configured to operably engage an anvil of thedisposable loading unit and apply a compressive pressure or force tosoft tissue prior to staples being deployed into the soft tissue. In atleast one embodiment, referring to FIGS. 82 and 83, disposable loadingunit 4016 can include anvil assembly 4020, staple cartridge assembly4018, and actuator 4043, where actuator 4043 can be configured to rotateanvil assembly 4020 between an open position, as illustrated in FIG. 82,and a closed position, as illustrated in FIG. 84. In variousembodiments, referring to FIGS. 82 and 84, actuator 4043 can include cam4053 where actuator 4043 can be pulled proximally, i.e., in a directionindicated by arrow “P”, such that cam 4053 can engage anvil assembly4020 and rotate anvil assembly 4020 about an axis defined by pivot tabs4211. Similar to the above, actuator 4043 can be operable engaged withany suitable trigger, such as articulation lever 30, for example, tomotivate actuator 4043.

In various embodiments, an actuator cam can include at least one of alinear, non-linear, arcuate, and/or curvilinear profile. In at least oneembodiment, cam 4053 can include an arcuate profile having apex 4055 andinitial contact point 4057, for example, where cam 4053 can beconfigured to engage anvil assembly 4020 such that initial contact point4057 first contacts anvil assembly 4020. As actuator 4043 is pulledfurther proximally, cam 4053 can slide relative to anvil assembly 4020such that various other points of cam 4053 contact anvil assembly 4020until apex 4055 is in contact with anvil assembly 4020 as illustrated inFIG. 85. At such point, anvil assembly 4020 can be in its closedposition. In various embodiments, referring again to FIG. 85, apex 4055can be positioned proximally relative to pivot tabs 4211, i.e., on theproximal side of axis 4059 and, as a result, anvil assembly 4020 can beprevented from rotating back into its open position until cam 4053 isdisengaged from, i.e., moved distally relative to, anvil assembly 4020.Furthermore, the position of apex 4055 relative to pivot tabs 4211 canutilize leverage, or mechanical advantage, to apply an even greaterclamping force to the soft tissue.

In various embodiments, as cam 4053 is retracted proximally and anvilassembly 4020 is rotated into its closed position as described above,anvil assembly 4020 can contact soft tissue, for example, positionedintermediate anvil assembly 4020 and staple cartridge assembly 4018. Inat least one embodiment, anvil assembly 4020 can apply an initialclamping force to the soft tissue when it initially contacts the tissueand wherein anvil assembly 4020 can apply an increasingly greater forceto the soft tissue as anvil assembly 4020 is moved into its final, orclosed, position. In various embodiments, the clamping force can beincreased in a substantially linear manner. In at least one embodiment,a cam, such as cam 4053, for example, can be configured to drive anvil4020 in such a manner as to increase the clamping force to the softtissue in a non-linear manner. In at least one such embodiment, theclamping force can be increased in a geometric manner such that theclimax of the clamping force is applied to the soft tissue when anvilassembly 4020 is in its final, or closed, position, for example. As aresult of the above, an anvil can apply a clamping force to soft tissueprior to staples being deployed from the staple cartridge, for example,and prevent, or at least inhibit, the soft tissue from flowing, or‘milking’, out of the distal end of the disposable loading unit.

In various embodiments, further to the above, a cam can include aprofile which utilizes a variable mechanical advantage as the anvil ismoved into its closed position. In at least one embodiment, the cam caninclude a compound profile which includes a first portion for utilizinga first mechanical advantage, or leverage, during the initial movementof the anvil and, in addition, a second portion for utilizing a secondmechanical advantage, or leverage, for subsequent movement of the anvil.In at least one such embodiment, a larger mechanical advantage can beutilized during the final movement of the anvil so as to apply a largerclamping force to the soft tissue when the anvil is in its closedposition.

In various embodiments, referring to FIGS. 84 and 85, anvil assembly4020 can include a tissue-contacting surface, such as surface 4063, forexample, which can be positioned parallel to, or at least substantiallyparallel to, a tissue-contacting surface on staple cartridge assembly4018, such as surface 4065, for example, when anvil assembly 4020 is inits closed position. In at least one embodiment, anvil assembly 4020 andstaple cartridge assembly 4018 can be configured such that there is agap defined between anvil assembly 4020 and staple cartridge assembly4018 when anvil assembly 4020 is in its closed position. In variousembodiments, the distance between tissue-contacting surfaces 4063 and4065 can be shorter at distal end 4069 of the disposable loading unit ascompared to proximal end 4067. In at least one such embodiment, as aresult, the distal end of anvil assembly 4020 can trap soft tissuewithin the disposable loading unit when anvil assembly 4020 is movedinto its closed position. In other various embodiments, the gap betweentissue-contacting surfaces 4063 and 4065 can have a consistent, or atleast a substantially consistent, distance between proximal end 4067 anddistal end 4069.

In various embodiments, referring to FIG. 86, an actuator, such asactuator 4043′, for example, can include two or more cams 4053 which canbe configured to engage at least a portion of anvil assembly 4020 asdescribed above. In at least one embodiment, cams 4053 can extend from ashaft portion 4061′ of actuator 4043′ such that cams 4053 can be movedrelative to anvil assembly 4020 simultaneously. In various embodiments,actuator 4043′ can also include at least one hook portion 258 configuredto engage first articulation link 123 as outlined further above. Invarious alternative embodiments, referring to FIG. 87, a disposableloading unit can include two or more actuators, such as actuators 4043″,for example, which can each include one or more cams 4053, for example,for pivoting anvil assembly 4020. In at least one such embodiment, eachactuator 4043″ can include a hook portion 258 which can be operablyconnected with one or more articulation links, for example, in asurgical stapling instrument.

In various embodiments of the present invention, a surgical staplinginstrument can include a disposable loading unit comprising a staplecartridge, an anvil, and a sleeve, wherein the sleeve can be configuredto be slid relative to the staple cartridge and the anvil and hold atleast one of the anvil and the staple cartridge in position. In at leastone embodiment, referring to FIGS. 109 and 110, disposable loading unit5016 can include at least one sleeve or collar, such as sleeve 5071, forexample, which can be slid between a proximal position, as illustratedin FIG. 109, and a distal position, as illustrated in FIG. 110. In atleast one embodiment, sleeve 5071 can include an aperture which, whensleeve 5071 is positioned in its distal position, for example, can atleast partially encompass or surround anvil assembly 5020 and/or staplecartridge assembly 5018. In various embodiments, sleeve 5071 can beconfigured to prevent anvil assembly 5020 from prematurely opening.Furthermore, sleeve 5071 can prevent, or at least inhibit, anvilassembly 5020 and staple cartridge assembly 5018 from deflecting whenthe soft tissue positioned therebetween is stapled and/or incised.

In at least one embodiment, sleeve 5071, for example, can be configuredto apply a clamping pressure or force to the soft tissue positionedbetween anvil assembly 5020 and staple cartridge assembly 5018. Invarious embodiments, similar to the above, such a clamping pressure orforce can be applied before surgical staples are deployed from thestaple cartridge and/or the soft tissue is incised. In variousembodiments, referring again to FIGS. 109 and 110, sleeve 5071 canfurther include slots 5079 which can be configured such that, whensleeve 5071 is advanced distally, sleeve 5071 may not contact and/ordamage the tissue positioned between anvil assembly 5020 and staplecartridge assembly 5018.

In various embodiments, a surgical stapling instrument can include acantilever, or tongue, configured to be slid relative to at least one ofa staple cartridge and an anvil and engage at least one of the staplecartridge and anvil to hold them in a closed position, for example. Inat least one embodiment, referring to FIGS. 111 and 112, disposableloading unit 6016 can include at least one sleeve or collar, such assleeve 6071, for example, which can be slid between a proximal position,as illustrated in FIG. 111, and a distal position, as illustrated inFIG. 112. In at least one embodiment, sleeve 6071 can include tongue6073 extending therefrom which can be configured to engage at least aportion of anvil assembly 6020 and apply a force thereto. In variousembodiments, such a force can position anvil assembly 6020 against thesoft tissue positioned intermediate anvil assembly 6020 and staplecartridge assembly 6018 and clamp the soft tissue therebetween.Referring to FIG. 113, tongue 6073, for example, can comprise anysuitable configuration including an arcuate, linear, and/or curvi-linearconfiguration. In at least one embodiment, tongue 6073 can include acurved body comprising proximal end 6075 connected to sleeve 6071 and adistal tip 6077 which can be configured to engage anvil assembly 6020within anvil cavity 6210. In at least one such embodiment, the forcetransmitted between tongue 6073 and anvil assembly 6020 can be appliedto anvil assembly 6020 through tip 6077 and, as a result, the locationin which the force is applied to the soft tissue can be dictated by theposition of tip 6077.

In various embodiments, sleeve 6071 can be configured such that it canbe advanced between its proximal and distal positions prior to staplesbeing deployed from staple cartridge assembly 6018 and the tissue beingincised by drive member 6212, for example. In at least one suchembodiment, referring to FIG. 113, tongue 6073 can be slid distally bysleeve 6071 until distal tip 6077 of tongue 6073 contacts anvil assembly6020 at distal end 6069. Thereafter, similar to the above, driveassembly 6212 can be advanced toward the distal end of the disposableloading unit to staple and/or incise the tissue. In such circumstances,the clamping force applied to the soft tissue by tongue 6073 can beapplied at the distal end of the disposable loading unit and thepossibility that the tissue may milk out of the distal end of thedisposable loading unit can be reduced. In other various embodiments,distal tip 6077 can be advanced toward distal end 6069 as drive member6212 is advanced toward distal end 6069, for example. In at least oneembodiment, distal tip 6077 can be configured to contact anvil assembly6020 at a location which is positioned directly over, or at leastadjacent to, knife blade 6280. In such embodiments, tongue 6073 cansupport anvil assembly 6020 directly above the location in which staplesare deformed against anvil assembly 6020.

After an anvil of a disposable loading unit has been moved into a closedposition, as outlined above, a drive beam can be advanced within thedisposable loading unit to eject the staples therefrom and/or incisesoft tissue. In various embodiments, a drive beam, such as drive beam266, for example, can be comprised of a single sheet of material and/ormultiple stacked sheets of material. As also outlined above, a driveassembly, such as drive assembly 212, for example, can further comprisea cam roller 286 and a support member 287 which can be configured toretain drive beam to anvil assembly 20 and staple cartridge assembly 18,respectively. In various circumstances, the time and cost to assemblesuch components to drive beam 266 can be significant. In variousembodiments of the present invention, such time and cost can be reduced.More particularly, in at least one embodiment of the present invention,a portion of a drive beam can be deformed, or otherwise integrallyformed, so as to create features which can obviate the need for aseparately-manufactured cam roller 286 and/or support member 287, forexample. In various embodiments, referring to FIGS. 88-90, drive beam1266 can include integral cam members 1286 which can extend laterallyfrom retention flange 1284. In at least one embodiment, drive beam 1266can manufactured from a flat, or at least substantially flat, piece ofmaterial where the piece of material can be stamped such that cammembers 1286 are at least partially separated from retention flange 1284and extend in a transverse or oblique direction with respect to drivebeam 1266. In at least one such embodiment, referring to FIG. 90, cammembers 1286 can be sized and configured such that they can slide withinanvil channel 1210 and at least assist in holding anvil assembly 1020 ina closed position. In addition to or in lieu of the above, although notillustrated, a portion of drive beam 1266, for example, can beconfigured to extend laterally from drive beam 1266 so as to retaindrive assembly 1212 to a staple cartridge assembly. In at least oneembodiment, similar to the above, retention flanges can be at leastpartially separated from drive beam 1266 during a stamping process suchthat the integral retention flanges extend in a transverse or obliquedirection with respect to drive beam 1266. In various embodiments, as aresult of the above, at least one integral cam member and/or at leastone integral retention member can be formed during a suitablemanufacturing process, such as progression stamping, for example, whichcan reduce, or even eliminate, the assembly time of additionalcomponents to the drive beam.

In various embodiments, referring to FIG. 49, the anvil of a disposableloading unit can include a slot defined therein which can be configuredto receive at least a portion of a drive beam. In at least oneembodiment, referring to FIGS. 51 and 52, the anvil can include achannel extending therethrough where cam rollers 286 can be configuredto engage a sidewall of the channel and apply a force, or forces, to theanvil assembly. In various circumstances, such forces can cause theanvil to elastically and/or plastically deform and, as a result, affectthe deployment of the surgical staples into the soft tissue. In variousembodiments of the present invention, an anvil can include featureswhich can eliminate, or at least reduce, the deformation of the anvil.In at least one embodiment, an anvil can include a first member havingstaple pockets for deforming the staples, a first cover plate secured tothe first member, and a second cover plate secured to at least one ofthe first member and the first cover plate, wherein the first and secondcover plates can be configured to support the first member. In at leastone such embodiment, referring to FIGS. 91-93, disposable loading unit7016 can include anvil assembly 7020 which can comprise anvil portion204, first cover plate 208 affixed to anvil portion 204, and secondcover plate 7081 affixed to at least one of anvil portion 204 and firstcover plate 208. In various embodiments, first cover plate 208 can bewelded to anvil portion 204 and, in addition, second cover plate 7081can be welded to first cover plate 208 and/or anvil portion 204. In atleast one embodiment, second cover plate 7081 can strengthen, stiffen,and/or increase the section modulus of the anvil assembly, therebyreducing the possibility that the anvil assembly may unsuitably deformduring use.

In various embodiments, referring to FIG. 91, first cover plate 208 caninclude tissue stops 208′ extending therefrom. In at least oneembodiment, tissue stops 208′ can be configured such that, when theanvil and staple cartridge assemblies are positioned relative to softtissue, tissue stops 208′ can prevent, or at least inhibit, the softtissue from progressing past a certain point in the disposable loadingunit. In various embodiments of the present invention, referring to FIG.94, second cover plate 7081 a of disposable loading unit 7016 a caninclude tissue stops 7081′ extending therefrom in addition to or in lieuof the above. In various embodiments, a disposable loading unit caninclude a second cover plate which can be formed from one or more sheetsof material. In at least one embodiment, referring to FIG. 95,disposable loading unit 7061 b can include second cover plate 7081 b,wherein second cover plate 7081 b can be formed from a single sheet ofmaterial, such as stainless steel, for example. In various embodiments,the sheet of material can be deformed over one or more forming anvils,or mandrels, until it is bent into a suitable shape. In at least oneembodiment, the sheet of material can include one or more side edges7083 b which can be positioned against or proximal to central portion7085 b of second cover plate 7081 b during the bending process.Thereafter, in at least one such embodiment, side edges 7083 b can beaffixed to central portion 7085 b by any suitable manufacturing process,such as welding, for example. As a result of the above, in variousembodiments, second cover plate 7081 b can include at least onetissue-contacting edge 7087 b which is formed at the bend between twoportions of the sheet material. In at least one such embodiment, thetissue-contacting edges 7087 b can have a rounded or radiused profilewhich can be configured such that the edges do not damage soft tissue.In various embodiments, further to the above, an anvil can be formedfrom a sheet of material wherein the formed anvil can include a centralportion having a first side and a second side and at least two flapsoppositely folded to one another with one flap on the first side and oneflap on the second side.

In various embodiments, referring to FIG. 95, first cover plate 208 andanvil member 204 can define anvil cavity 210 therebetween. In at leastone embodiment, as described above, cavity 210 can be configured toreceive cam actuators 286 and, in various circumstances, first coverplate 208 can be configured such that there are large gaps between camactuators 286 and the sidewalls of cavity 210. In such an embodiment,however, the configuration of first cover plate 208 may not be optimizedso as to maximize the moment of inertia of the anvil assembly withrespect to axis 7089 b, for example. As known in the art, a devicehaving a larger moment of inertia with respect to an axis can be moreresistant to bending or deformation with respect to that axis. Thus, invarious embodiments of the present invention, a cover plate of an anvilassembly can be configured such that the gaps between cam actuators 286and the cover plate can be eliminated, or at least reduced. In at leastone embodiment, referring to FIG. 96, first cover plate 7208 c caninclude at least one base portion 7093 c and at least one side wall 7095c positioned adjacent to, or in abutting contact with, cam actuators286. In such embodiments, side walls 7095 c can extend in a direction soas to increase the moment of inertia of first cover plate 7208 c withrespect to axis 7089 b. In various embodiments, side wall portions 7095c can be oriented in perpendicular, or at least substantiallyperpendicular, directions with respect to base portions 7093 c.

In various embodiments, further to the above, an anvil assembly caninclude a first and/or second cover plate which can include ribs and/orfolds therein which can strengthen or stiffen the anvil assembly. In atleast one embodiment, referring to FIG. 97, an anvil assembly ofdisposable loading unit 7016 d can include anvil portion 204 and coverplate 7208 d attached to anvil portion 204. In various embodiments,cover plate 7208 d can be include ribs or folds 7097 d which canincrease the moment of inertia of cover plate 7208 d with respect toaxis 7089 b. In at least one embodiment, cover plate 7208 d can bemanufactured from one or more sheets of material, such as stainlesssteel, for example, where the sheet, or sheets, can be bent into theconfiguration illustrated in FIG. 97. As known in the art, the moment ofinertia of a cross-section can be increased by increasing the mass ofthe cross-section and/or increasing the distance between a mass and areference axis. The ribs and/or folds 7097 d, as they can add additionalmass at a distance from axis 7089 b, can add to the moment of inertia ofcover plate 7208 d as compared to cover plate 208, for example.

In various embodiments, as described above, two or more components of ananvil assembly can be welded together. In at least one embodiment of thepresent invention, two or more components of an anvil assembly can bepress-fit together such that the components are retained to one another.In various embodiments, referring to FIGS. 98-101, anvil assembly 8020can include insert portion 8099 and cover portion 8101 where, referringto FIGS. 98 and 100, insert portion 8099 can be positioned within cavity8103 defined by cover portion 8101. Thereafter, referring to FIG. 101,at least a portion of cover portion 8101 can be deformed, stamped, orswaged such that at least a portion of insert portion 8099 is capturedwithin cavity 8103. In at least one embodiment, insert portion 8099 caninclude uneven, rough, and/or corrugated surfaces which can beconfigured to interlock with portions of cover portion 8101 when it isdeformed.

In various embodiments, referring to FIG. 100, cavity 8103 can includeslots or grooves 8105 which can be configured to slidably receive tines8107 of insert portion 8099 therein, wherein cover portion 8101 can bedeformed to capture tines, or arms, 8107 in grooves 8105. In at leastone embodiment, arms 8107 can be press-fit into grooves 8105 where, invarious circumstances, such a press-fit can be sufficient to retaininsert portion 8099 within cover portion 8101. In various embodiments,the cover and insert portions of the anvil assembly can be constructedfrom the same material or different materials. In at least oneembodiment, the cover portion can be comprised of a softer or moremalleable material than the insert portion. In at least one suchembodiment, the cover portion can be at least partially comprised ofaluminum, for example, and the insert portion can be at least partiallycomprised of steel, for example. In either event, the cover portion canbe comprised of a material which can be stamped or coined to form thestaple-deforming pockets therein. In at least one such embodiment, thecover portion can then be anodized.

In various embodiments, as described above, an anvil assembly cancomprise an anvil portion have staple-deforming pockets therein and acover plate for supporting the anvil portion. In at least oneembodiment, the anvil portion and the cover plate can be integrallyformed. Referring to FIGS. 102-103, anvil 8020 a can be manufacturedfrom a tube, or annulus, of material where, in at least one embodiment,at least a portion of the tube, such as portion 8109 a, for example, canbe removed. In at least one such embodiment, the remaining portion ofthe tube, such as portion 8111 a, for example, can be deformed utilizinga stamping or forming process such that anvil 8020 a can includeco-planar, or at least substantially co-planar, anvil portions 8204 aextending from support portion 8208 a. In various embodiments, the tubecan be at least partially comprised of extruded aluminum and, in atleast one embodiment, staple-deforming cavities 206 can be formed in thetube prior to and/or after the portion of the tube is removed.

In various embodiments, as described above, an anvil assembly can becomprised of two or more components which are press-fit together. In atleast one embodiment, referring to FIGS. 105 and 106, anvil assembly8020 b can include a first, or insert, portion 8099 b and a second, orcover, portion 8101 b, wherein insert portion 8099 b can be insertedinto cavity 8103 b of cover portion 8101 b. In at least one embodiment,the outer surface of insert portion 8099 b can define a perimeter whichis larger than a perimeter defined by an outer surface of outer portion8101 b wherein, as a result, insert portion 8099 b can expand outerportion 8101 b outwardly when insert portion 8099 b is inserted intocavity 8103 b. Owing to such co-operating geometries, a significantnormal force can be generated between the surfaces of portions 8099 band 8101 b. In at least one such embodiment, as a result, a significantpulling force may be required to overcome the friction force betweenmembers 8099 b and 8101 b resulting from the high normal forcetherebetween.

In various embodiments, an anvil assembly can be comprised of two ormore components which are snap-fit together. In at least one embodiment,referring to FIGS. 106-108, anvil assembly 8020 c can include firstportion 8099 c and second portion 8101 c, where second portion 8101 ccan be snap-fit to first portion 8099 c. Referring to FIG. 109, in atleast one embodiment, second portion 8101 c can include projections 8113c extending therefrom which can be configured to fit within grooves 8115c. In various embodiments, second portion 8101 c can be at leastpartially comprised of a resilient material, such as stainless steel,for example, which can allow projections 8113 c to be displacedoutwardly as surface 8117 c of second portion 8101 c is moved towardsurface 8119 c of first portion 8099 c. Once surface 8117 c ispositioned against or adjacent to surface 8119 c, projections 8113 c canbe resiliently positioned within, or snapped into, grooves 8115 c suchthat second portion 8101 c is retained to first portion 8099 c. In atleast one embodiment, the first and second portions can be comprised ofthe same material or they can be comprised of different materials. In atleast one embodiment, first portion 8099 c can be at least partiallycomprised of aluminum and second portion 8101 c can support the firstportion.

In various embodiments, referring to FIG. 86, an anvil can include ananvil member, such as anvil member 4204, for example, which can includeribs or ridges 4153 extending therefrom. In at least one embodiment,ribs 4153 can increase the moment of inertia or cross-sectional modulusof anvil member 4204, for example, such that anvil assembly 4020 is lesssusceptible to unwanted deformation. In various embodiments, ribs 4153can extend around the perimeter of anvil member 4204.

In various embodiments, although not illustrated, other components canbe assembled to an anvil. In at least one embodiment, a soft or pliablenosepiece, for example, can be assembled to the anvil in order to reducethe possibility that the anvil may damage soft tissue when it isinserted into a surgical site. In at least one such embodiment, thenosepiece, or any other suitable component, can be comprised of anysuitable material such as rubber and/or nylon, for example.

In various embodiments, as described above, cam actuators 286, forexample, can be configured to engage an anvil assembly and position theanvil assembly against soft tissue positioned intermediate the anvilassembly and a staple cartridge. In at least one embodiment of thepresent invention, referring to FIGS. 104 and 105, anvil assembly 8020b, for example, can include contact surface, or surfaces, 8121 b,wherein cam actuators 286 can be configured to engage contact surfaces8121 b and hold anvil assembly 8020 b in a closed position. In variousembodiments, contact surfaces 8121 b can be configured such that theyextend inwardly toward drive beam 1266 such that at least a portion ofthe contact surfaces are positioned adjacent to, or in contact with,drive beam 1266. In at least one embodiment, as a result, contactsurfaces 8121 b can be configured such that the contact area between camactuators 286 and contact surfaces 8121 b can be maximized, or at leastincreased. As a result of the increased contact area, the stress orpressure applied by actuators 286 to contact surfaces 8121 b can bereduced and the possibility of galling and/or localized yielding of theanvil assembly can be reduced.

In various circumstances, especially during endoscopic or laparoscopicsurgical procedures, for example, at least a portion of a surgicalstapling instrument can be inserted through a cannula, or trocar, into asurgical site. Often, an anvil of a disposable loading unit is movedinto its closed position before it is inserted into the trocar and thenreopened after it has been inserted therethrough. Some disposableloading units having large anvils and/or staple cartridges may not fit,or easily fit, through the trocar even when the anvil is in the closedposition. In various embodiments of the present invention, a surgicalstapling instrument can include a disposable loading unit having ananvil which can be moved between open, closed, and/or collapsedpositions to facilitate the insertion of the disposable loading unitthrough the trocar. More particularly, in at least one embodiment, ananvil can be moved into a closed position in which the anvil is a firstdistance away from the staple cartridge, for example, and a collapsedposition in which the anvil is closer to the staple cartridge such thatthe disposable loading unit can be more easily inserted through thetrocar.

In various embodiments of the present invention, further to the aboveand referring to FIGS. 114-116, a disposable loading unit 9016 caninclude anvil assembly 9020 and staple cartridge assembly 9018, whereinanvil assembly 9020 can be rotatably mounted relative to staplecartridge assembly 9018. In use, similar to the above, drive assembly212 can be advanced distally such that cam actuators 286 can contactanvil member 9204 and rotate anvil assembly 9020 between an openposition, as illustrated in FIGS. 115 and 116, and a closed position, asillustrated in FIGS. 117 and 118. When anvil assembly 9020 is rotatedtoward staple cartridge assembly 9018, in at least one embodiment, anvilassembly 9020 can be configured to compress at least one return spring9051, for example, in the disposable loading unit.

In at least one embodiment, referring to FIG. 118, anvil assembly 9020can further include tissue-contacting surface 9020′ and, similarly,staple cartridge assembly 9018 can include tissue contacting surface9018′. In various embodiments, tissue-contacting surfaces 9018′ and9020′ can be separated by a first distance 9121 when anvil assembly 9020is in a closed position. In order to move anvil assembly 9020 into acollapsed position, in various embodiments, actuator 9043 can be moveddistally, for example, such that portion 9049 of actuator 9043 cancontact anvil assembly 9020 and push anvil assembly 9020 toward staplecartridge assembly 9018 as illustrated in FIGS. 119 and 120. In such acollapsed position, in at least one embodiment, tissue-contactingsurfaces 9018′ and 9020′ can be separated by a second distance 9125which can be shorter than first distance 9121. In various embodiments,actuator 9043 can push anvil assembly 9020 downwardly until surface9020′ at least partially abuts surface 9018′.

In various embodiments, further to the above, a disposable loading unitcan include at least one return spring which can be compressed when theanvil assembly is moved into its collapsed position. In at least oneembodiment, referring to FIGS. 116 and 118, disposable loading unit 9016can include springs 9123 which can be compressed when anvil assembly9020 is moved between its open and closed positions and, referring toFIGS. 118 and 120, further compressed when anvil assembly is moved intoits collapsed position. Once the anvil assembly is in its collapsedposition, the disposable loading unit can be inserted into a trocar,which is represented in dash as circle 9155 in FIG. 121. After at leasta portion of anvil assembly 9020 and staple cartridge assembly 9018 havepassed through the trocar, actuator 9043 can be disengaged from anvilassembly 9020 to allow springs 9123 to move anvil assembly from itscollapsed position into its closed position, as illustrated in FIG. 122.Furthermore, cam actuators 286 can be sufficiently disengaged from anvilassembly 9020 to allow springs 9051 to move anvil assembly 9020 into itsopen position such that the anvil and staple cartridge assemblies can bepositioned relative to soft tissue.

In various embodiments, as outlined above, cam actuators 286 can beutilized to move anvil assembly 9020 between an open position and aclosed position and, thereafter, actuator 9043 can be utilized to moveanvil assembly 9020 between the closed position and a collapsedposition. Alternatively, actuator 9043 can be configured such that itcan engage anvil assembly 9020 when it is in its open position and moveanvil assembly 9020 directly into its collapsed position. In variouscircumstances, such embodiments can allow a surgeon to more quickly andeasily configure a disposable loading unit to be inserted through atrocar. In at least one such embodiment, after at least a portion of theanvil assembly has been inserted through the trocar, the actuator can besufficiently disengaged from the anvil assembly such that the anvilassembly can be moved directly into is open position and positionedrelative to soft tissue, for example. In order to remove the disposableloading unit from the surgical site, the actuator can be reengaged withthe anvil assembly to move the anvil assembly into its collapsedposition such that the disposable loading unit can be withdrawn throughthe trocar.

With respect to the disposable loading units and surgical instrumentsdescribed further above, referring to FIGS. 41 and 42, a disposableloading unit can be inserted into the distal end of a surgicalinstrument and can be rotated with respect to the surgical instrument inorder to operably engage the drive assembly and/or articulation link ofthe disposable loading unit with the surgical instrument. In at leastone embodiment of the present invention, such rotation can unlock thedrive assembly and allow the drive assembly to be advanced distally asdescribed above. Referring to FIG. 123, disposable loading unit 10016can include anvil assembly 10020, shaft assembly 10125, and lockoutdevice 10127, where lockout device 10127 can be engaged with driveassembly 10212 (FIG. 128) prior to disposable loading unit 10016 beingrotated relative to elongated body 14 (FIG. 1) of the surgicalinstrument. In at least one such embodiment, referring to FIG. 124,lockout device 10127 can include key 10131 which can be configured toengage a recess in drive assembly 10212, for example, so as to prevent,or at least inhibit, drive assembly 10212 from being advanced distallyprior to disposable loading unit 10016 being rotated. As disposableloading unit 10016 is rotated, key 10131 can be disengaged from driveassembly 10212 and, as a result, drive assembly 10212 can be advanceddistally as described above.

In various embodiments, referring to FIGS. 123 and 124, lockout device10127 can include arms 10129 extending therefrom which, prior to therotation of disposable loading unit 10016, can be aligned, or at leastsubstantially aligned, with nubs 254 extending from shaft assembly10125. In at least one embodiment, referring to FIGS. 125 and 126, arms10129 and nubs 254 can be inserted into slots 10133 in elongated body14, for example, when disposable loading unit 10016 is inserted intoelongated body 14. When disposable loading unit 10016 is rotated,referring to FIG. 127, arms 10129 can be sufficiently confined withinslots 10133 such that slots 10133 can hold them in position, whereasnubs 254 can be positioned such that they are not confined within slots10133 and can be rotated relative to arms 10129. In effect, elongatedbody 14 can hold lockout device 10127 in position and, when shaftassembly 10125 is rotated with disposable loading unit 10016, driveassembly 10212 can be rotated away from key 10131 of lockout device10127.

To detach disposable loading unit 10116 from elongated member 14,disposable loading unit 10016, and shaft assembly 10125, can be rotatedin an opposite direction such that nubs 254 are at least substantiallyrealigned with arms 10129 and, as a result, nubs 254 and arms 10129 canbe withdrawn from slots 10133. Such circumstances can typically ariseafter the disposable loading unit has been used, or expended, and thesurgeon, or other clinician, desires to assemble a new disposableloading unit to the elongated body. In various circumstances, though,the surgeon, or other clinician, may become confused as to whether adisposable loading unit has been previously expended. In variousembodiments of the present invention, the lockout device describedabove, or any other suitable lockout device disclosed herein, can beutilized to prevent, or at least inhibit, an expended disposable loadingunit from being reassembled to the elongated body of the surgicalinstrument.

In various embodiments, referring to FIG. 128, disposable loading unit10016 can further include biasing spring 10135, actuator 10137, andactuator plate 10139 extending from actuator 10137, wherein actuatorplate 10139 can be configured to operably engage spring 10135. Afterdisposable loading unit 10116 has been operably engaged with elongatedportion 14, as described above, drive assembly 10212 can be advanceddistally to staple and/or incise tissue. In at least one embodiment,actuator 10137 can be operably attached to drive assembly 10212 suchthat, when drive assembly 10212 is advanced, drive assembly 10212 canpull actuator 10137 and actuator plate 10139 distally as well. Oncedrive assembly 10212 has been sufficiently advanced, referring to FIG.129, actuator plate 10139 can be sufficiently disengaged from biasingspring 10135 so as to release biasing spring 10135 from a compressedstate and allow biasing spring 10135 to apply a biasing force againstlockout device 10127. However, at such point, as lockout device 10127 isheld in position by elongated member 14, as described above, the biasingforce applied by spring 10135 cannot move, or at least substantiallymove, lockout device 10127, at least as long as disposable loading unit10016 remains engaged with elongated member 14.

In various embodiments, the disengagement of actuator plate 10139 frombiasing spring 10135 can occur before, or at the exact moment, in whicha staple can de deployed from the staple cartridge and/or the cuttingmember can incise the tissue. In at least one such embodiment, a surgeoncould advance and retract drive assembly 10212 in order to positionanvil assembly 10020 relative to soft tissue without triggering thelockout assembly described above. After actuator 10137 has beensufficiently advanced to disengage plate 10139 from spring 10135, driveassembly 10212 can be further advanced distally such that, referringagain to FIG. 129, actuator 10137 and/or actuator plate 10139 can abut ashoulder, for example, within the disposable loading unit. In at leastone such embodiment, the shoulder can prevent actuator 10137 andactuator plate 10139 from being advanced further within the disposableloading unit. Upon further advancement of drive assembly 10212, however,actuator 10137 can become operably detached from drive assembly 10212such that the advancement of drive assembly 10212 is not transmitted toactuator 10137.

After disposable loading unit 10016 has been disengaged from elongatedmember 14, referring to FIG. 130, biasing spring 10135 can move, orrotate, locking device 10127 into a position in which arms 10129 are nolonger aligned with nubs 254. In at least one such embodiment, such adisposable loading unit 10016 cannot be readily reassembled to elongatedmember 14 as arms 10129 and nubs 254 would not both fit within slots10133 owing to their relative misalignment. In various embodiments, suchdisposable loading units can provide the surgeon, or other clinician,with immediate feedback that they are attempting to assemble anexpended, or possibly defective, disposable loading unit to a surgicalinstrument. Such embodiments can ameliorate the circumstances where anat least partially expended disposable loading unit is reassembled to asurgical instrument and reinserted into a surgical site only for thesurgeon to then discover that the disposable loading unit has beenexpended. In various embodiments, drive assembly 10212 and actuator10137 can be configured such that, in the event that drive assembly10212 is retracted, drive assembly 10212 may not cause actuator 10137 toreengage biasing spring 10135 and return biasing spring 10135 to itscompressed state.

In various embodiments, referring primarily to FIG. 126, slots 10133 ofelongated member 14 can include a substantially rectangular profilewhich extends along the length thereof. While suitable for its intendedpurpose, circumstances may arise where it may be difficult to assemblethe disposable loading unit to the elongated member. More particularly,in at least one embodiment, the disposable loading unit can beconfigured such that a surgeon, or other clinician, can not readilyobserve whether nubs 254 are aligned with slots 10133 and the surgeonmay have spend time to precisely align nubs 254 with slots 10133 beforeassembling the disposable loading unit to elongated member 14. In atleast one embodiment of the present invention, referring to FIG. 64,elongated member 14′ can include slots 10133′ having radiused and/orbeveled ends 10141′ which can facilitate the insertion of nubs 254 intoslots 10133′ and reduce the time and/or effort that a surgeon mustexpend to align and assemble the disposable loading unit to the surgicalinstrument.

As described above, a disposable loading unit can be detached from asurgical instrument after it has been at least partially expended and anew disposable loading unit can be attached to the surgical instrumentsuch that the surgical instrument can be reused. In various embodiments,previous disposable loading units have included a housing, an anvilassembly, and a staple cartridge assembly, as outlined above, and, inaddition, a staple driver for deploying staples from the staplecartridge assembly and a cutting member for incising tissue. When thestaple cartridge assemblies of such disposable loading units are atleast partially expended, the remainder of the disposable loading unit,such as the housing, the anvil assembly, the staple driver, and thecutting member, for example, are typically discarded along with theexpended staple cartridge assembly. As a result, significant cost andundue waste can be expended to replace such previous disposable loadingunits.

In various embodiments of the present invention, a disposable loadingunit can include a replaceable staple cartridge. In at least oneembodiment, referring to FIGS. 131-135, disposable loading unit 11016can include anvil assembly 11020, staple cartridge channel 11216, andstaple cartridge 11018, wherein staple cartridge 11018 can be removablyattached to staple cartridge channel 11216. In at least one embodiment,as a result, a first staple cartridge 11018 can be replaced with asecond staple cartridge 11018, or another suitable staple cartridge,such that one or more of the various other portions of the disposableloading unit can be reused. In various embodiments, referring to FIG.132, staple cartridge 11018 can be snap-fit into staple cartridgechannel 11216 such that staple cartridge 11018 can be reliably retainedwithin, yet easily removed from, staple cartridge channel 11216.

In at least one embodiment, staple cartridge 11018 can include bodyportion 11143 having at least one staple cavity for removably storing atleast one staple therein and, in addition, cartridge pan 11145 which canbe attached to body portion 11143. In various embodiments, cartridge pan11145 can be snap-fit and/or press-fit to body portion 11143 to prevent,or at least inhibit, the staples within the staple cavities from fallingout of the bottom of body portion 11143. In at least one embodiment,body portion 11143 and/or cartridge pan 11145 can include one or moreprojections 11147 and/or apertures 11149 which can be configured toretain body portion 11143 and cartridge pan 11145 to one another. Invarious embodiments, cartridge pan 11145 can further include projectionsor dimples 11151, for example, which can be configured to engage staplecartridge channel 11216 and retain staple cartridge 11018 thereto.

In various embodiments, as described above, staple driver 232 andcutting member 280 can be advanced distally to deploy staples from thestaple cartridge and incise soft tissue. Thereafter, in at least oneembodiment of the present invention, staple driver 232 and cuttingmember 280 can be retracted relative to the staple cartridge such that,when the staple cartridge is replaced, staple driver 232 and cuttingmember 280 can be advanced distally once again into the new staplecartridge. In various embodiments, the staple driver and/or cuttingmember can remain in the spent staple cartridge as the staple cartridgeis being removed and the new staple cartridge can include a new stapledriver positioned therein. In at least one such embodiment, each staplecartridge can include a staple driver and a cutting member positionedtherein such that the staple driver and cutting member of a spent staplecartridge do not have to be reused. Such embodiments can be useful whenthe staple driver and the cutting member can be damaged and/or dulledduring their use. In various embodiments, the staple driver and thecutting member can comprise an assembly. In at least one suchembodiment, the cutting member can be snap-fit and/or press-fit into thestaple driver. In other embodiments, the cutting member can be comprisedof a plastic material, for example, which is overmolded onto the cuttingmember.

As described above, an anvil assembly of a disposable loading unit caninclude one or more pockets therein for deforming at least one staplewhen it is ejected from the staple cartridge. In various embodiments ofthe present invention, an anvil can be attached to the disposableloading unit such that it cannot be readily detached from the disposableloading unit even though the staple cartridge may be readily removable.In various circumstances, however, the anvil may become worn after asingle use and/or multiple uses. In at least one embodiment of thepresent invention, at least a portion of an anvil assembly can beconfigured such that it can be detached from disposable loading unit andreplaced with a new portion of the anvil assembly. In at least one suchembodiment, the anvil assembly and the staple cartridge can both bereplaced before a disposable loading unit is reused. In variousembodiments, further to the above, a disposable loading unit can includea staple cartridge channel, or at least a portion of a staple cartridgechannel, which is detachable from the disposable loading unit. In atleast one such embodiment, the staple cartridge channel, or a portion ofthe staple cartridge channel, can be replaced along with a staplecartridge.

When a staple cartridge and/or anvil of a disposable loading unit isreplaced, in various embodiments of the present invention, the staplecartridge and anvil can be replaced with an identical, or at leastnearly identical, staple cartridge and anvil. In at least one suchembodiment, for example, a 30 mm staple cartridge can be replaced withanother 30 mm staple cartridge. In at least one embodiment, however, thestaple cartridge and/or anvil can be replaced with a different staplecartridge and anvil. In at least one such embodiment, a 30 mm staplecartridge can be replaced with a 45 mm staple cartridge. Suchembodiments may be particularly useful when the anvil assembly and/orstaple cartridge channel are also replaced to accommodate the differentstaple cartridge. Other embodiments are envisioned in which a staplecartridge is replaced with a staple cartridge having a differentquantity and/or arrangement of staples stored therein. In suchembodiments, similar to the above, at least a portion of the anvilassembly can be replaced to accommodate such a staple cartridge. Invarious embodiments, sets of anvils and staple cartridges can beprovided for and/or with a disposable loading unit. In at least one suchembodiment, a rigid anvil can be provided for use with a staplecartridge containing staples which will require a large force to deformthe staples. In other various embodiments, an anvil can be providedhaving specialized staple-deforming pockets which are particularlydesigned to deform a particular staple, such as staples with long staplelegs, for example. In at least one embodiment, the anvil and staplecartridge can include corresponding indicia, such as colors, numbers,and/or symbols, etc. which can allow a surgeon, or other clinician, toreadily identify matching pairs of anvils and staple cartridges.

Several of the disposable loading unit embodiments described above havebeen exemplified with an anvil having a distal end which is movablerelative to a distal end of a staple cartridge. In various alternativeembodiments, although not illustrated, a disposable loading unit caninclude an anvil and a staple cartridge wherein the anvil can include adistal end which is pivotably mounted relative to the staple cartridgeat its distal end. In at least one embodiment, the disposable loadingunit can include an actuator which can be displaced distally to engagethe anvil and rotate the anvil between an open position and a closedposition. In at least one such embodiment, the staple cartridge caninclude a staple cartridge and/or a cutting member which can bedisplaced from a position located near the distal end of the anvil to aproximal end of the anvil. In at least one such embodiment, as a result,a surgeon can more readily observe whether soft tissue has been properlypositioned between and/or treated within the staple cartridge and anvil.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the stapling apparatus neednot apply staples but rather may apply two part fasteners as is known inthe art. Further, the length of the linear row of staples or fastenersmay be modified to meet the requirements of a particular surgicalprocedure. Thus, the length of a single stroke of the actuation shaftand/or the length of the linear row of staples and/or fasteners within adisposable loading unit may be varied accordingly. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the claimsappended thereto.

What is claimed is:
 1. A disposable loading unit for use with a surgicalstapling instrument, said disposable loading unit comprising: a shaftportion comprising a proximal end, wherein said proximal end comprises abayonet connection which is rotated to operably connect said disposableloading unit with the surgical stapling instrument; a selectivelyreplaceable first jaw, comprising: a cartridge body comprising aplurality of staple cavities; a plurality of staples removably stored insaid staple cavities; staple drivers configured to eject said staplesfrom said staple cavities; and a retainer extending around a bottomportion of said cartridge body configured to prevent said staple driversfrom falling out of said cartridge body through said bottom portion,wherein said replaceable first jaw extends around a bottom portion ofsaid retainer such that said retainer is positioned intermediate saidcartridge body and said replaceable first jaw; a second jaw comprisingan anvil configured to deform said staples; a firing member configuredto eject said staples from said staple cavities during a firing strokeof said firing member, wherein said selectively replaceable first jawcan be replaced after said firing stroke without having to replace theentirety of said disposable loading unit, and wherein said firing memberis further configured to deploy staples from another selectivelyreplaceable first jaw with which said selectively replaceable first jawis replaced; and a lockout configured to selectively prevent said firingmember from being advanced through said firing stroke when saiddisposable loading unit is in a clamped configuration.
 2. The disposableloading unit of claim 1, wherein said lockout is configured to preventsaid replaceable first jaw from being re-fired with said disposableloading unit after said first jaw has already been at least partiallyfired.
 3. A replaceable disposable loading unit for use with a surgicalstapling instrument, said replaceable disposable loading unitcomprising: a shaft portion comprising a proximal end operablyengageable with the surgical stapling instrument; a replaceable firstjaw, comprising: a cartridge body comprising a plurality of staplecavities; a plurality of staples removably stored in said staplecavities; staple drivers configured to eject said staples from saidstaple cavities; and a retainer extending around a bottom portion ofsaid cartridge body configured to prevent said staple drivers fromfalling out of said cartridge body through said bottom portion, whereinsaid replaceable first jaw extends around a bottom portion of saidretainer such that said retainer is positioned intermediate saidcartridge body and said replaceable first jaw; a second jaw comprisingan anvil configured to deform said staples; a firing member configuredto eject said staples from said staple cavities during a firing strokeof said firing member, wherein said firing member is further configuredto deploy staples from another selectively replaceable first jaw withwhich said selectively replaceable first jaw is replaced; and a lockoutconfigured to selectively prevent said firing member from being advancedthrough said firing stroke when said replaceable disposable loading unitis in a clamped configuration.
 4. A surgical stapling system,comprising: a surgical instrument comprising a handle and a shaftextending from said handle; a replaceable disposable loading unit,comprising: a shaft portion comprising a proximal end, wherein saidproximal end comprises a bayonet connection which is rotated to operablyconnect said disposable loading unit with said shaft of said surgicalinstrument; a selectively replaceable first jaw, comprising: a cartridgebody comprising a plurality of staple cavities; and a plurality ofstaples removably stored in said staple cavities; staple driversconfigured to eject said staples from said staple cavities; and aretainer extending around a bottom portion of said cartridge bodyconfigured to prevent said staple drivers from falling out of saidcartridge body through said bottom portion, wherein said replaceablefirst jaw extends around a bottom portion of said retainer such thatsaid retainer is positioned intermediate said cartridge body and saidreplaceable first jaw; a second jaw comprising an anvil configured todeform said staples; and a lockout; and a firing member configured toeject said staples from said staple cavities during a firing stroke ofsaid firing member, wherein said selectively replaceable first jaw canbe replaced after said firing stroke without having to replace theentirety of said replaceable disposable loading unit, wherein saidfiring member is further configured to deploy staples from anotherselectively replaceable first jaw with which said selectivelyreplaceable first jaw is replaced, and wherein said lockout isconfigured to selectively prevent said firing member from being advancedthrough said firing stroke when said replaceable disposable loading unitis in a clamped configuration.
 5. The surgical stapling system of claim4, wherein said lockout is configured to prevent said replaceable firstjaw from being re-fired with said disposable loading unit after saidfirst jaw has already been at least partially fired.